Category: Drug & Cosmetic Law

Internal Revenue Service (IRS) Capitalized Legal Fees Incurred by Pharmaceutical Company

 

McDermottLogo_2c_rgbIn a recently released Field Attorney Advice, the Internal Revenue Service (IRS) Office of Chief Counsel concluded that a pharmaceutical company must capitalize legal fees incurred to obtain Food and Drug Administration approval for marketing and selling generic drugs and to prevent the marketing and sale of a competing generic drug.  The IRS Office of Chief Counsel also concluded that it could impose an adjustment on audit to capitalize legal fees that the taxpayer expensed in prior years, including years closed by statute of limitations.

In a recently published Internal Revenue Service (IRS) Field Attorney Advice (FAA 20131001F, March 8, 2013), the IRS Office of Chief Counsel concluded that a pharmaceutical company must capitalize legal fees incurred to obtain U.S. Food and Drug Administration (FDA) approval for marketing and selling new generic drugs and to prevent the marketing and sale of a competing generic drug.  The IRS also concluded that the Commissioner could change the taxpayer’s method of accounting for the legal fees and impose an adjustment on audit to capitalize legal fees that the taxpayer expensed in prior years, including years closed by the statute of limitations.

NDA and ANDA

In order to market or sell a new drug in the United States, a New Drug Application (NDA) must be submitted to and approved by the FDA.  An NDA consists of clinical and nonclinical data on the drug’s safety and effectiveness, as well as a full description of the methods, facilities and quality controls employed during manufacturing and packaging.  An NDA also must disclose all the patents that cover the drug.

To market or sell a generic version of an existing FDA-approved drug, the maker of the generic drug must submit an Abbreviated New Drug Application (ANDA) for FDA approval.  An ANDA generally is not required to include preclinical and clinical trial data to establish safety and effectiveness.  Instead, an ANDA applicant must show that its generic drug is bioequivalent to an existing drug.  In addition, an ANDA applicant is required to provide certification that the ANDA will not infringe on the patent rights of a third party.  Specifically, if an applicant seeks approval prior to the expiration of patents listed by the NDA holder, then a “paragraph IV certification” must be submitted by the applicant to certify that it believes its product or the use of its product does not infringe on the third party’s patents, or that such patents are not valid or enforceable.  The first generic drug applicant that files an ANDA containing a paragraph IV certification is granted, upon approval, 180 days of marketing exclusivity.

For an ANDA with a paragraph IV certification, the applicant must send notices to the NDA holder for the referenced drug and to all patentees of record for the listed patents within 20 days of FDA notification that the ANDA is accepted for filing.  If neither the NDA holder nor the patent holders bring an infringement lawsuit against the ANDA applicant within 45 days, the FDA may approve the ANDA.  If the NDA holder or the patent holders file a patent infringement lawsuit against the ANDA applicant within 45 days, a stay prevents the FDA from approving the ANDA for up to 30 months.  If, however, the patent infringement litigation is still ongoing after the 30 months, the FDA may approve the ANDA.

The Facts

The taxpayer is a pharmaceutical company engaged in developing, manufacturing, marketing, selling and distributing generic and brand name drugs.  In the process of filing ANDAs with a paragraph IV certification, the taxpayer incurred legal fees in lawsuits filed by patent and NDA holders for patent infringement.  In addition, the taxpayer as an NDA holder incurred legal fees in a lawsuit it filed against an ANDA applicant with a paragraph IV certification to protect its right to sell its branded drug until all patents expired.  The taxpayer sought to deduct its legal fees as ordinary and necessary business expenses.

The IRS Analysis

Legal Fees Incurred in the Process of Obtaining FDA Approval of ANDAs

The IRS concluded that the legal fees incurred by the taxpayer as an ANDA applicant to defend actions for patent infringement in the process of filing the ANDA with paragraph IV certification must be capitalized under Treas. Reg. § 1.263(a)-4.  The IRS characterized the fees as incurred to facilitate the taxpayer obtaining the FDA-approved ANDAs with paragraph IV certification, which granted the applicant the right to market and sell a generic drug before the expiration of the patents covering the branded drugs, and by filing early, potentially with a 180-day exclusivity period.  As such, the IRS concluded, the fees are required to be capitalized as amounts paid to create or facilitate the creation of an intangible under Treas. Reg. § 1.263(a)-4(d)(5).  In so concluding, the IRS rejected the taxpayer’s argument that its fees did not facilitate obtaining FDA-approved ANDAs because it could have commercialized its generic drugs after the 30-month stay expired regardless of the outcome of the lawsuits.  The IRS reasoned that the filing of the ANDAs with paragraph IV certification and the defense of the patent infringement lawsuit were a part of a series of steps undertaken in pursuit of a single plan to create an intangible.

The IRS further concluded that the cost recovery of the capitalized legal fees incurred to obtain the FDA-approved ANDAs must be suspended until the FDA approves the ANDAs, and the capitalized fees must be amortized on a straight-line basis over 15 years as section 197 intangibles.

Legal Fees Incurred to Protect Its Right Against Other ANDA Applicants with Paragraph IV Certification

With respect to the legal fees incurred by the taxpayer as an NDA holder in the litigation against another ANDA applicant, the IRS characterized the fees incurred to defend the validity of the patents owned by the taxpayer as amounts paid to defend or perfect title to intangible property that are required to be capitalized under Treas. Reg. § 1.263(a)-4(d)(9).  In contrast, the fees incurred by the taxpayer in the litigation relating to determining whether valid patents have been infringed are not required to be capitalized under Treas. Reg. § 1.263(a)-4(d)(9).

The IRS further concluded that the capitalized fees incurred to protect the patents and the FDA-approved NDA must be added to the basis of the patents to be depreciated under section 167.  The cost recovery begins in the months in which the legal fees were incurred and is allocated over the remaining useful lives of the patents.

In characterizing the legal fees incurred by the taxpayer in defending the validity of its patents as costs of defending or perfecting title to intangible property, the IRS distinguished the legal fees at issue from the litigation expenses incurred by the taxpayers in defending a claim that their patents were invalid in Urquhart v. Comm’r, 215 F.2d 17 (3rd Cir. 1954).  In Urquhart, the taxpayers were participants in a joint venture that was engaged in the business of inventing and licensing patents.  The taxpayers obtained two patents involving fire-fighting equipment and, after threatening litigation against Pyrene Manufacturing Company, brought an infringement suit against a customer of Pyrene, seeking an injunction and recovery of profits and damages.  The case was dismissed, and Pyrene subsequently commenced an action against the taxpayers seeking a judgment that the taxpayers’ patents were invalid and that its own apparatus and methods did not infringe the patents.  A counterclaim was filed for an injunction against infringement, and an accounting for profits and damages.  Pyrene did not raise any questions as to title to, or ownership of, the patents and was successful in the lawsuit.  The patents held by the taxpayers were found to be invalid.  In holding that the legal fees incurred by the taxpayer were deductible as ordinary and necessary business expenses, the U.S. Court of Appeals for the Third Circuit rejected the IRS’s contention that the litigation was for the defense or protection of title.

Distinguishing the FAA from Urquhart, the IRS focused on the fact that the taxpayers in Urquhart were professional inventors engaged in the business of exploiting and licensing patents, and that Urquhart involved the taxpayers’ claims for recovering lost profits.  By emphasizing that Pyrene did not raise any issue as to title to the patents in Urquhart, the IRS seemed to ignore the fact that, like the taxpayer in the FAA, Pyrene sought a judgment on the validity of the taxpayers’ patents and that the outcome of the litigation in Urquhart also focused on the validity of the patents.

Change of Accounting Method for Legal Fees Incurred by the Taxpayer 

The IRS also concluded that the taxpayer’s treatment of its legal fess associated with each ANDA or patent as either deductible or capitalizable is a method of accounting that the Commissioner can change on an ANDA-by-ANDA or patent-by-patent basis.  The consequence of this conclusion, if valid, is that the IRS can impose on audit an adjustment to capitalize legal fees that the taxpayer deducted in prior years, including years closed by the statute of limitations.  For example, the IRS can include in the taxpayer’s gross income for the earliest year under examination an adjustment equal to the amount of the legal fees the taxpayer previously deducted, less the amount of amortization that the taxpayer properly could have taken had the taxpayer capitalized the legal fees.

A taxpayer that voluntarily changes its method of accounting, however, receives more favorable terms and conditions than a taxpayer that has its method of accounting changed by the IRS on examination.  For example, a taxpayer that changes its method of accounting voluntarily can spread the adjustment resulting from the change over four taxable years, and the first year of the adjustment is the current taxable year as opposed to the earliest open taxable year.

The publication of this FAA likely will bring the attention of examining agents to this issue.  Therefore, if a taxpayer believes it is using an improper method of accounting for legal fees (or any other item), it should carefully consider whether to voluntarily change its method of accounting before the IRS proposes to change the taxpayer’s method of accounting on examination.

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FTC Proposes Amendments to HSR Rules Targeting Certain Pharmaceutical Licensing Arrangements

The National Law Review recently published an article by Robert G. Kidwell and Farrah Short of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. regarding Pharmaceutical Licensing:

 

The Federal Trade Commission (FTC) recently announced proposed amendments to the Premerger Notification Rules (HSR Rules) to clarify reporting requirements under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), for transactions involving the transfer of patent rights in the pharmaceutical industry. The proposed rule is largely a codification of the FTC’s current treatment of exclusive licenses, with one significant change regarding the weight given to manufacturing rights retained by the licensor in pharmaceutical transactions.

The HSR Act requires parties engaged in certain transactions (involving the acquisition of voting securities, assets, or controlling non-corporate interests) to file a notification with the FTC and the Antitrust Division of the Department of Justice (DOJ), and to observe the statutorily prescribed waiting period prior to closing. Theacquisition of a patent is treated as an asset acquisition, and thus a potentially reportable transaction under the HSR Act. However, whether the transfer of rightsto a patent is also deemed an asset acquisition commonly involves a complex analysis focused on whether the transferred rights grant the licensee theexclusive right to “make, use and sell.”

Commercially Significant Rights

The proposed amendments would codify the reporting requirement under the HSR Act for any transaction within the pharmaceutical industry that involves the transfer of “all commercially significant rights.” These rights are defined as the exclusive patent rights to use the patent in a particular therapeutic area or in a specific indication within a therapeutic area.

The FTC has defined the pharmaceutical industry for purposes of this amendment by specifying NAICS (North American Industry Classification System) code 3254, which includes medical and botanical manufacturing, pharmaceutical preparation manufacturing, in-vitro diagnostic substance manufacturing, and biological product manufacturing. Importantly, the FTC’s proposed amendments are limited to the pharmaceutical industry and do not change the current HSR Act reporting requirements related to exclusive licenses in other industries.

Retained Manufacturing Rights

Under current FTC practice, transactions where the licensor retains the right tomanufacture are generally deemed non-exclusive and thus non-reportable under the HSR Act, even if the licensee obtains exclusive rights to use and sell under the patent. These transactions historically have been viewed as distribution agreements, rather than asset acquisitions.

The FTC, however, has determined that the right to manufacture in pharmaceutical licensing arrangements is far less important than the right to commercialize (use and sell) the product. Therefore, the FTC’s proposed amendment treats these types of exclusive arrangements in the pharmaceutical industry — where the licensee obtains the exclusive right to use and sell but the licensor retains the right to manufacture — as the transfer of “all commercially significant rights” and thus potentially reportable under the HSR Act. This change would represent a significant departure from the FTC’s current practice.

Retained “Co-Rights”

In certain licensing arrangements, the licensor often retains “co-rights” when granting an otherwise exclusive license. For example, in the pharmaceutical industry, co-rights provide for the shared responsibility between the licensor and the licensee to see the licensed product through the Food and Drug Administration (FDA) approval process, and the subsequent marketing and promotion of the product (often referred to as “co-development” and “co-marketing” rights). Under current FTC practice, the retention of these co-rights by the licensor does not render the license non-exclusive, therefore they remain potentially reportable licensing arrangements under the HSR Act. The proposed amendments would simply codify this approach without making any change to current practice.

The proposed amendments would modify the HSR Rules contained in 16 C.F.R. §801.1 and §801.2. Click here for the text of the Federal Register Notice, and the full language of the proposed amendments. Comments regarding the proposed amendment must be submitted to the FTC by October 25, 2012.

©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

First-Ever Electronic Medical Records and Advanced Imaging Technology Being Brought to 2012 London Olympics

For the first time in Olympic history, advanced imaging technology will be used to help detect athletes’ use of performance-enhancing drugs.  GE Healthcare Life Sciences’ biomolecular imager will lend a big hand in helping to test athletes for recombinant erythropoietin (EPO), a performance-enhancing drug used to boost the number of red blood cells, which enables improved oxygen flow and allows athletes to raise their workout intensity and endurance.  The GE provided equipment, the ImageQuant LAS4000, uses technology that offers extremely detailed information to accurately identify EPO doping.  We first saw the popularity of this drug grow among Tour de France cyclists.

Many other tests will be performed, in addition to the EPO test, in an attempt to create the most advanced drug testing laboratory in the history of the Olympics.  GlaxoSmithKline will be the official lab services provider for the 2012 Olympic and Paralympics Games.  Test results will be analyzed at King’s College London, within an independently operated World Anti-Doping Agency (WADA) accredited laboratory.  The average number of samples analyzed throughout the year at King’s College is approximately 7,000, but during the Olympic Games, it is expected that 5,000 samples will be analyzed in only 17 days.

The history of drug testing in the Olympics dates back to the 1968 Olympic Games in Mexico City.  Many notable athletes have had world records and Olympic medals rescinded due to testing positively for performance-enhancing drugs in post-race drug testing, others have had to resign from their Olympic team just weeks before competing on the world stage due to failed drug tests, and still others have received lifetime bans from the games.  With the rapid advancement of technology within medical imaging and testing, we are likely to see a closer eye on the issue of doping in the Olympics.  While we can begin to feel reassurance from advanced testing such as that provided by GE’s ImageQuant, some of us may be watching this year’s Olympic Games with a skeptical eye about what has gone on before…

©2012 Drinker Biddle & Reath LLP

Still Waiting for Guidance on Informed Consent of Decisionally-Impaired Subjects

A July 11, 2012 article by Gina Kolata in the New York Times describes a recent discovery of a rare gene mutation that protects people from Alzheimer’s disease by slowing the production of beta amyloid.  Excessive amounts of beta amyloid in the brain are believed to cause Alzheimer’s.  The discovery bolsters hope that drugs, currently in development, that reduce levels of brain amyloid will prove effective in slowing the progression of Alzheimer’s.

The lack of clear guidelines for enrolling in clinical research decisionally-impaired subjects, or those who may become impaired over the course of a study  may hinder efforts to conduct trials of Alzheimer’s drugs.  In 2010, an Institute of Medicine summary  of a workshop on the state of clinical trials in the United States noted that 27% of investigators in the U.S. failed to enroll any subjects in trials in which they agreed to participate, and 90% of all clinical trials worldwide fail to enroll the target number of subjects on time and must extend their enrollment periods.  Though the federal Office for Human Research Protections and the Secretary’s Advisory Committee on Human Research Protections have considered the issue of participation of decisionally-impaired subjects in research in recent years, no guidance has been released.  Further, few states’ laws explicitly address who has authority to consent to research participation on behalf a decisionally-impaired individual.

In the absence of clear guidance, to be in the best position to participate in Alzheimer’s research and other research involving subjects who are or may become decisionally-impaired, institutions and their IRBs should develop their own policies on enrollment of and consent for decisionally-impaired subjects and subjects whose capacity may diminish over the course of a study.  Having policies in place before opportunities to participate in such studies arise will help ensure consistent and efficient review by institutions and IRBs.  Individuals who have a strong interest in participating in Alzheimer’s research studies should complete health care power of attorney documents, record their wishes in writing, and discuss them with their designated health care agents.

©2012 Drinker Biddle & Reath LLP

FDA Issues Proposed Rule on Medical Device Labeling

The National Law Review recently published an article regarding Medical Device Labeling written by William O. Jackson of von Briesen & Roper, S.C.:

On July 10, the Food and Drug Administration (FDA) released a proposed ruleon medical device labeling. The FDA promulgated the rule to “substantially reduce existing obstacles” to medical device identification. Among other benefits the FDA recognized, the rule is intended to reduce medical errors due to misidentification or incorrect medical device use and improve reporting of adverse events caused by devices.

Under the proposed rule, medical devices are required to have a unique device identifier (UDI) with a standard date format (e.g., JAN 1, 2012). The UDI will also identify the specific version or model of the device, the labeler of the device, and a production identifier, such as a lot or batch number, a serial number, an expiration date, or a manufacture date. The UDI must be in two forms: easily-readable plain-text and automatic identification and data capture (AIDC) technology format.

Subject to limited exceptions, every medical device will require a UDI. Excepted medical devices include (but are not limited to) non-prescription devices sold at retail establishments; a device used solely for research, teaching, or chemical analysis, and not intended for any clinical use; and exported medical devices. The proposed rule also has a procedure to request an exception from or alternative to the UDI requirements.

The FDA plans to phase in the UDI requirement. Class III medical devices and devices licensed under the Public Health Service Act must be labeled within one year after publication of the UDI final rule. Class II medical devices must be labeled within three years. Class I medical devices must be labeled within five years.  Finally, the proposed rule contains reporting requirements, including requiring “labelers” to submit data to the Global Unique Device Identification Database.

The FDA’s press release on the proposed rule is available here. For an example of a UDI, click here.

©2012 von Briesen & Roper, s.c

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

  • Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
  • Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
  • Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
  • Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
  • Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
  • Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
  • Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

  • Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
  • Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
  • Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
  • Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
  • Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
  • Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
  • Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma

Supreme Court Decision Opens Door for Possible Implied Conflict Preemption of Over-the-Counter Drugs

The National Law Review recently published an article, Supreme Court Decision Opens Door for Possible Implied Conflict Preemption of Over-the-Counter Drugs, by David B. Sudzus, B. Todd Vinson, and Russell J. Chibe of Drinker Biddle & Reath LLP:

The United States Supreme Court’s most recentpronouncement on federal preemption, decided in the context of generic prescription drugs, appears destined to be at the forefront in future battles over unsettled questions regarding preemption in the context of nonprescription, over-the-counter (OTC) drugs. InPLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law preempted state law failure to warn claims asserted against generic drug manufacturers. The Court’s preemption holdings, couched in terms of “impossibility” borne out of federal regulatory requirements of “sameness,” could arguably have similar applicability in the context of OTC drugs regulated under the FDA’s “monograph” regime.

The doctrine of federal preemption is based on the Supremacy Clause of the United States Constitution. The Supremacy Clause provides that federal law is “the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. As such, any state law that conflicts with the exercise of federal power is preempted and has no effect. SeeMaryland v. Louisiana, 451 U.S. 725, 747 (1981).

State law is preempted under the Supremacy Clause where Congress has expressly preempted state law. See, e.g., Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, (1992). Preemption may also be implied to the extent that state law actually conflicts with federal law. English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). “Implied” or “conflict” preemption exists where (1) it is impossible for a private party to comply with both state and federal requirements; or (2) state law obstructs accomplishing and executing Congress’ full purposes and objectives. SeeMensing, 131 S. Ct. 2567 (citing Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). In Mensing, the Supreme Court addressed implied preemption based on impossibility.

 Impossibility-Based Federal Preemption as Articulated by Supreme Court in Mensing

Mensing involved state law failure to warn claims asserted against generic prescription drug manufacturers, and alleged the manufacturers failed to provide adequate warning labels. Plaintiffs claimed that state law required the manufacturers to use a different, safer label.

However, the Mensing Court determined that, under FDA regulations, generic drug manufacturers have an ongoing federal duty of “sameness” regarding their labels – namely, that the generic drug’s labeling must at all times be the same as the brand name drug’s labeling because the brand name drug is the basis for generic drug approval. Specifically, the Court found that the generic drug manufacturers could not strengthen their labels through the FDA’s “changes-being-effected” (CBE) process, as such action would constitute a unilateral change by the generic drug manufacturers violating federal regulations requiring a generic drug’s label to match its brand name counterpart. 131 S. Ct. at 2575.

The Court distinguished its prior 2009 decision in Wyeth v. Levine (holding that state law failure to warn claims were not preempted against a brand name prescription drug manufacturer) based on this difference in availability of the CBE process. The Court explained that Wyeth turned on its finding that it was not impossible for Wyeth to strengthen its product warnings because Wyeth could take advantage of CBE provisions applicable to brand name prescription drugs approved under the New Drug Application (NDA) procedure and change its labeling without first seeking FDA approval. Id. at 2581. Thus, the Mensing Court reasoned that, unlike the case before it, the availability of the CBE regulations permitted the brand name drug manufacturer to “unilaterally strengthen its warning” without prior FDA approval, and therefore “allowed the company, on its own volition, to strengthen its label in compliance with its state tort duty.” Id.

The Mensing plaintiffs nonetheless argued against a finding of impossibility by contending that, despite the federal requirement of “sameness” and lack of CBE availability, the generic drug manufacturers were still able to (or even were required to) propose stronger warning labels to the FDA if they believed such warnings were needed. Id. at 2575. The Mensing Court, however, reasoned that simply proposing label changes “would not have satisfied the requirements of state law,” but rather “federal law would permit the Manufacturers to comply with the state labeling requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name label.” Id. at 2578. This, according to the Court, “raise[d] the novel question of whether conflict preemption should take into account these possible actions by the FDA . . . .” Id. The Mensing Court held that it should not:

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it. . .

***

If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express preemption, the Supremacy Clause would have any force. We do not read the Supremacy Clause to permit an approach to preemption that renders conflict preemption all but meaningless . . .

***

To consider in our preemption analysis the contingencies inherent in these cases – in which the Manufacturer’s ability to comply with state law depended on uncertain federal agency and third-party decisions – would be inconsistent with the non obstante provision of the Supremacy Clause . . .

Id. at 2579-80. The Mensing Court summarized the test for “impossibility” as follows:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for [preemption] purposes.

Id. at 2581.

Impact of Mensing’s Test for Impossibility in Context of OTC Drugs Preemption

The Mensing articulation of impossibility arguably provides compelling grounds for finding impossibility-based preemption in the context of failure to warn claims asserted against OTC drug manufacturers. Specifically, manufacturers of OTC drugs regulated under the FDA’s “monograph” system could persuasively argue that, similar to the generic prescription drug manufacturers in Mensing, their product labeling is subject to federal requirements of “sameness” that cannot be unilaterally changed without FDA permission and assistance.

Lack of Express Preemption for OTC Drugs Does Not Foreclose Arguing Implied Preemption

An initial hurdle facing OTC drug manufacturers asserting implied preemption lies in reconciling the fact that Congress specifically carved out state product liability claims (including presumably, failure to warn claims) from the reach of an express preemption clause applicable to OTC drugs. The Federal Food, Drug and Cosmetic Act (FDCA) governing OTC nonprescription drugs contains an express preemption clause, but then sets forth a “saving clause” stating that “[n]othing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.” 21 U.S.C. § 379r(a), (e).

Nevertheless, the Supreme Court has recognized that the existence of an express preemption provision and saving clause does not foreclose application of the doctrine of implied conflict preemption. In Buckman v. Plaintiffs’ Legal Committee, the Court recognized that “neither an express preemption provision nor a savings clause bars the ordinary working of conflict preemption principles.” 531 U.S. 341, 352 (2001) (citing Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000)).

“Monograph” Regulation of OTC Drugs

The FDA regulates most OTC drugs under its “monograph” regime. A monograph is a set of regulations promulgated by the FDA through notice and comment rulemaking that describes the conditions under which a category of drugs may be marketed without a prescription.

The Final Monograph for a class of OTC drugs includes labeling requirements. The manufacturer of an OTC drug must use the warning language authored by the FDA. 21 C.F.R. § 330.1(c)(2). The FDA’s labeling requirements are designed to provide warnings reflecting known risks based on reliable scientific evidence. See generally 21 C.F.R. § 330.10(a) (procedure for establishing OTC monograph). Adequate warnings are those that, in the judgment of the FDA, are “clear and truthful in all respects, not misleading in any particular,” and that accurately communicate the benefit to risk ratio and the proper use of the product in terms “likely to be read and understood by the ordinary individual.” 21 C.F.R. § 330.10(a)(4)(v).

Compliance with the Final Monograph by the OTC drug manufacturer is mandatory. “Any product which fails to conform to an applicable monograph after its effective date is liable to regulatory action.” 21 C.F.R. § 330.10(b). Therefore, once a Final Monograph goes into effect, it is illegal to sell a drug described therein unless it conforms to the monograph. 21 U.S.C. §§ 332-334. If a drug is marketed without prior FDA approval or without complying with an applicable monograph, the United States may bring an enforcement action under the FDCA. Enforcement measures include seizure of the drug product, civil injunction against its sale and criminal penalties against the violator.

“Sameness” of Labeling Imposed on Final Monograph OTC Drugs

Mensing’s articulation of impossibility arguably provides compelling grounds for finding impossibility-based preemption in the context of failure to warn claims asserted against Final Monograph OTC drug manufacturers. Specifically, manufacturers of Final Monograph OTC drugs could persuasively argue that, similar to the generic prescription drug manufacturers in Mensing, their product labeling is subject to federal requirements of “sameness” that cannot be unilaterally changed without FDA permission and assistance.

Final Monograph OTC drug manufacturers could assert that federal regulations, providing for specific product labeling and making it illegal to sell an OTC drug unless it conforms to the monograph, make it impossible for the manufacturer to comply with the federal law and also provide the additional or different labeling sought under the state law failure to warn claims. Moreover, the OTC drug manufacturers would assert that the monograph regime does not contain any directly applicable CBE provision—a critical distinction made by the Mensing Court in distinguishing its holding from Wyeth.

Finally, the OTC drug manufacturers could argue that under Mensing, the fact that FDA regulations provide a mechanism to amend or repeal any final monograph based on consideration of new information related to the safety or effectiveness of OTC products in the category does not change the impossibility preemption result. As Mensing held, impossibility preemption does not take into account possibleactions by the FDA. As such, the OTC drug manufacturer could argue that the mechanism for potential amendment or repeal of a final monograph does not allow it to “satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency,” and thus it “cannot independently satisfy those state law duties for [preemption] purposes” through such means. 131 S. Ct. at 2581.

Conclusion

The law of federal preemption regarding claims against drug manufacturers—whether brand name or generic, prescription or over-the-counter—is constantly evolving, and promises to remain in flux in the immediate wake of Mensing. Key holdings in Mensing provide OTC drug manufacturers with plausible, though far from certain to prevail, impossibility-based preemption arguments to challenge failure to warn claims. Whether Mensing ultimately provides a path to preemption for OTC drug manufacturers should become more clear in the future as courts across the country begin to interpret Mensing’s impact in non-generic OTC drug contexts.

©2012 Drinker Biddle & Reath LLP.

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

  • Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
  • Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
  • Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
  • Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
  • Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
  • Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
  • Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012

The National Law Review is pleased to bring you information about an upcoming conference:

5th Product and Pipeline Enhancement for Generics Conference, July 17-19, 2012 in Washington, DC

The marcus evans 5th Product and Pipeline Enhancement for Generics Conference will host industry leaders within the Generic Pharmaceutical, Branded Pharmaceutical and API industries operating globally as they share best practices, strategies and tools on portfolio management and business strategy, as well as legal, intellectual property and patent issues.

Featuring case studies from leading generics experts, including:

  • Richard Dicicco, Chairman at Harvest Moon Pharmaceutical
  • Dr. Vijay Soni, Executive Vice President, IP, BD and Product Portfolio at Glenmark Pharmceuticals
  • Candis Edwards, Senior Vice President, Regulatory Affairs & Compliance at Amneal Pharmaceuticals
  • Gregory Fernengel, Senior Intellectual Property Counsel at Ben Venue Laboratories, Inc.
  • Markus H. Meier, Assistant Director, Health Care Division, Bureau of Compensation at Federal Trade Commission
  • Vishal K. Gupta, Chief Scientific Officer, Vice President, Research & Development at CorePharmaLLC
  • Sherri Leonard, VP, Business Development and Portfolio Management at OrchidPharma, Inc.

Attendees will leave this conference with a better understanding of:
1. Current and upcoming FDA proposals and regulations to ensure compliance
2. Innovation in the drug pipeline
3. Portfolio management and business development
4. How to protect the company’s patents’ and intellectual property
5. Expanding the commercial reach through biosimilars
6. Market changes and future industry developments

Testimonials:

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

”Terrific chance to connect with other industry traders to exchange ideas and explore solutions to the challenges we all face.” – OrchidPharma