Tag: HHS

FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

Beveridge & Diamond PC environmental and energy law firm

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and 1,4-butanediol (“BDO”) – as psychotropic substances under Schedule I of the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”). See 80 Fed. Reg. 4283.  The comments will be used by the Secretary of Health and Human Services (“HHS”) to prepare a recommendation on the WHO proposal to the Secretary of State, which will be binding on the U.S. representative to the upcoming 58th Session of the UN Commission on Narcotic Drugs (“CND”) in Vienna, Austria, on March 9-17, 2015.  At the Vienna meeting, CND may accept the WHO recommendations, reject the recommendations, or decide to control the chemicals in another way (i.e., under a different Schedule of the Convention).

FDA notes that if either chemical – or any of the other chemicals that are also recommended for listing, but are not addressed here because they have few, if any, legitimate industrial uses – are added by CND to Schedule I of the Psychotropic Convention, the U.S. will have to impose additional controls on the chemical(s) under the Controlled Substances Act (“CSA”) administered by the Drug Enforcement Administration (“DEA”).  Although FDA does not elaborate on what those controls might consist of, they would likely include additional restrictions on manufacture, distribution, import, and export of the chemicals, as well as enhanced recordkeeping and reporting requirements. For example, Article 2(7)(a)(i) of the Psychotropic Convention states that parties shall require licenses for manufacture, trade, and distribution of Schedule I substances.  Moreover, Article 7(a) provides that parties must “[p]rohibit all use [of Schedule I substances] except for scientific and very limited medical purposes by duly authorized persons,” although Article 2(7)(a) allows individual parties to notify the UN that they cannot do so as a result of “exceptional circumstances,” in which case the party need only “take into account” the prohibition “as far as possible.”

It is worth noting that GBL is already regulated under the CSA as a precursor to gamma-hydroxybutyric acid (“GHB”), which is a commonly abused central nervous system depressant drug that is currently regulated under Schedule II of the Psychotropic Convention and Schedule I of the CSA.  In particular, GBL is classified under the CSA as a “List I” precursor (not to be confused with a CSA Schedule I or other controlled substance), and thus is already subject to significant DEA controls.  In addition, some U.S. states and authorities in some other countries already regulate GBL directly as a controlled substance or its equivalent.  Nevertheless, the addition of GBL to Schedule I of the Convention would likely require new and more stringent controls in most jurisdictions.  Additional information on the basis for the WHO recommendation for GBL (including the chemistry of the chemical, abuse potential, legitimate uses, and current regulation around the world) can be found in the 2014 GBL Critical Review Report of the WHO Expert Committee on Drug Dependence.

BDO is also a precursor to GHB, but is not currently regulated under the CSA.  It is regulated in several U.S. states and other countries as a precursor or controlled substance equivalent.  Once again, however, if it is added to Schedule I of the Psychotropic Convention, it will likely become subject to substantial additional restrictions.  Additional information on the basis for the WHO recommendation for BDO can be found in 2014 BDO Critical Review Report of the WHO Expert Committee on Drug Dependence.

FDA will accept written comments on the WHO recommendations until February 26, 2015.  Requests for a public meeting will be accepted until February 6, 2015.

ARTICLE BY

Aaron H. Goldberg
OF
Beveridge & Diamond PC

Health Resources and Services Administration (HRSA) Withdraws 340B Program Proposed Rule

Mcdermott Will Emery Law Firm

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the 340B Federal Drug Pricing Program.  The “mega rule,” which had been submitted to the White House Office of Management and Budget in April 2014, was expected to cover important 340B Program matters, such as patient eligibility, contract pharmacy arrangements, and eligibility for hospitals and off-site facilities.  Now, in lieu of the proposed rule, HRSA has announced its intention to release notice-and-comment guidance to “address key policy issues raised by various stakeholders committed to the integrity” of the 340B Program.  Additionally, HRSA plans to issue proposed rules related to civil monetary penalties for manufacturers, calculating the 340B ceiling price and administrative dispute resolution.

The decision to withdraw the proposed rule, coupled with HRSA’s intention to release regulatory guidance on similar issues, may be viewed as a response by HHS to a recent federal court decision limiting HHS’s ability to promulgate notice-and-comment rules.  In a May 23, 2014, decision, the U.S. District Court for the District of Columbia held that HHS did not have the requisite statutory authority to promulgate a notice-and-comment rule pertaining to the purchase of orphan drugs by certain Covered Entities.  Further, the withdrawal may indicate a decision by HRSA to scale back its issuance of notice-and-comment rules for the 340B Program, limiting formal rulemaking to areas where the statutory authority to do so is explicit.  The withdrawal of the proposed mega rule demonstrates HRSA’s position that it does not possess the broad authority necessary to issue a formal rule of this scope.

Without the proposed rule, important facets of the 340B Program remain uncertain.  Manufacturers and Covered Entities that sought guidance on key practical issues such as patient definition now must continue to wait for clarification.  As noted, going forward HRSA will seek to clarify “key policy issues” but has yet to announce whether the topics covered by the proposed rule will be addressed.  HRSA’s regulatory guidance on these issues may never come, however, if the U.S. District Court for the District of Columbia (which is hearing further briefing on the aforementioned case concerning HHS’s regulatory guidance on the orphan drug rule) further restricts HHS’s ability to issue guidance.

In the face of continuing uncertainty, 340B Program participants, including Covered Entities, should stay current and closely follow available guidance from HRSA and the 340B Prime Vendor (Apexus).  Until clear guidance has been issued pertaining to subjects such as patient definition and contract pharmacy compliance, 340B Program participants should continue to follow and document best practices to ensure compliance with all 340B Program requirements.

ARTICLE BY

David S. Ivill
Emily J. Cook
Joseph M. Parise
OF
McDermott Will & Emery

Ebola Response Missing A Critical Player

Covington BUrling Law Firm

The Obama Administration has mobilized a number of government agencies to respond to the Ebola crisis in West Africa and to prevent its spread into the U.S. At the frontline of the Administration’s response is the Pentagon, the Department of Health and Human Services, the Center for Disease Control, the U.S. Agency for International development and, more recently, the Department of Transportation.

Conspicuously missing, however, is the Department of Commerce, which traditionally is the link to the U.S. private sector.

This omission is significant because U.S. companies are likely to get materials to the stricken countries of Liberia, Sierra Leone and Guinea more quickly than the Pentagon.  In the instances in which they operate locally, the companies provide a valuable source of information and delivery infrastructure.

For example, in mid-August, more than 20 leading medical companies shipped 40 tons of supplies and protective equipment to Liberia.  The airlift was coordinated  by the California-based NGO, Direct Relief, and facilitated by Fedex. Companies such as Pfizer, Teva, Merck, Kimberly-Clark and Mylan Laboratories contributed 2.3 million gloves, 65,000 masks and 185,000 tabs of antibiotics. As of September 20th, Direct Relief had coordinated 11 shipments of supplies.

Equally important is the Ebola Private Sector Mobilization Group (EPSMG) which is a network of more than 40 companies active in West Africa and, especially, Liberia, Guinea and Sierra Leone. Chaired by ArcelorMittal and including companies such as Chevron, Rio Tinto and BHP Billiton, the group seeks to provide a single access point for the private sector to help mobilize and coordinate a response.  The group’s first principal is to “be part of the region’s long-term economic and social recovery and development.” EPSMG has met with Dr. Margaret Chan, Director General of the World Health Organization, and the U.S. ambassador to Liberia, Deborah Malac, and engaged with organizations such as the UN Ebola Task Force, the World Bank and various NGOs.

The in-country private sector plays other important roles.  ArcelorMittal, which has a workforce of nearly 3000, provides health care for its workers and their families and uses its internal communications network to convey accurate and timely information about the epidemic.  Firestone Rubber, which has been in Liberia since 1926, detected in first case of Ebola on March 30th, according to NPR. Since then, the company went into crisis mode, built its own treatment center and developed a comprehensive response that effectively stopped the transmission of the virus among more than 80,000 employees and family members who live on the sprawling plantation.

Local companies such as the National Oil Company of Liberia and the Sierra Leone Produce Marketing Company have also made contributions to combatting the virus.

The importance of the private sector’s role in responding to health emergencies cannot be underestimated.  Companies such as Anglo-American, SABMiller and Ford Motor Company played critical roles in combatting the HIV/AIDS crisis in South Africa by making medicines and quality health care available to their employees and their families, and they continue to play this role.

The U.S. Chamber of Commerce and the Corporate Council on Africa are to be applauded for the role that they have played in helping to coordinate and publicize the U.S. private sector response to the Ebola crises.

The Obama Administration has effectively integrated the private sector into key development initiatives such as Power Africa and the New Alliance for Food Security and Nutrition, which is the private sector component of Feed the Future.  It would do well to establish a similar mechanism as part of its Ebola response. Controlling the spread of Ebola and the development of viable health care systems in the three affected countries will require the sustained engagement of governments, NGOs, international organizations and agencies and the private sector.  The sooner that all parties are able to coordinate their efforts the more likely this virus will be controlled.

© 2014 Covington & Burling LLP
ARTICLE BY

Witney Schneidman
OF
Covington & Burling LLP

The Government Shut Down and Its Impact on Public Health

MintzLogo2010_Black

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for several more months but delayed implementation of key portions of the Affordable Care Act (ACA) for one year.

The impact of the shutdown will be felt across all healthcare sectors as many federal employees face furloughs of unknown duration. In particular, the Department of Health and Human Services (HHS) announced in its Contingency Staffing Plan that over half of its employees will be furloughed. HHS’s Plan is based upon federal guidance that allows agency programs to continue only if they either do not rely on annual appropriations, or they involve the safety of human life or the protection of property.[1] According to HHS, the following programs and services will continue:

  • Funding for Medicaid and the Child Health Insurance Program will continue uninterrupted because funding has already been set aside for these programs.
  • Funding for Medicare will likewise continue uninterrupted but only in the short term. If the political impasse stretches beyond several weeks, the program could be disrupted by the reduction in HHS staff.
  • The Centers for Medicare & Medicaid Services (CMS) will continue to implement the ACA, “including coordination between Medicaid and the Marketplace, as well as insurance rate reviews, and assessment of a portion of insurance premiums that are used on medical services.”[2]
  • State and federal health insurance exchange programs will open as planned, though it is not clear how the information technology (IT) that underpins the exchanges will function since they are operated by government contractors.[3]
  • The National Institute of Health (NIH) will continue to provide patient care for current NIH Clinical Center[4] patients
  • The Food and Drug Administration (FDA) will be able to operate only for “vital activities” such as high risk recalls and other “critical public health issues.”
  • Substance Abuse and Mental Health Services Administration will continue programs such as the Suicide Prevention Lifeline using the balance of available grants.
  • Other programs supported through mandatory funding such as the Centers for Disease Control and Prevention (CDC) Global HIV/AIDS Program will continue.

However, several programs important to public health will be disrupted if a congressional compromise cannot soon be reached. For example:

  • Outside of matters related to “imminent threats to the safety of human life or protection of property,” CMS, FDA, NIH and other federal agencies will not publish regulations or other guidance during the shutdown.
  • CMS will not fund task forces that work to prevent healthcare fraud and abuse, and will scale back on Medicare provider audits.
  • The CDC seasonal influenza program, which tracks flu outbreaks and certain infectious diseases, will come to a halt.
  • No new patients will be admitted to the NIH Clinical Center. NIH-funded researchers may continue to work for as long as their money holds out but additional funds will not be released during the shutdown.
  • The FDA will not be able to support much of its food safety activities, such as routine inspections and public notification programs. The FDA’s laboratory research and some compliance and enforcement activities will be suspended.
  • No action will be taken on any grants related to medical research, improvement of the healthcare system, and monitoring of substance abuse programs.

Although providers can take comfort in the fact that Medicare and Medicaid program reimbursement will proceed, a government shutdown for any period of time beyond three or four weeks could impede certain critical administrative functions, such as Medicare claims processing, and therefore impact their pocketbooks. Likewise, while substantial ACA implementation will continue, long term furloughs could affect certain components of the law (such as the exchanges) because they depend on government employees to help run the IT component, among other aspects of the program. Thus, the magnitude of the shutdown’s impact will depend on how long it endures.

*Copyright 2013, American Health Lawyers Association, Washington, DC. Reprint permission granted.

[1]/ Opinion of the Office of Legal Counsel, Department of Justice, Government Operations in the Event of a Lapse in Appropriations, 1995 WL 17216091 (Aug.16, 1995) at pp. 3-4: see also, Effect of Appropriations for Other Agencies and Branches on the Authority to Continue Department of Justice Functions During the Lapse in the Department’s Appropriations, 19 Op. O.L.C. 337, 1995 WL 917146 (Dec. 13, 1995).

[2]/ Contingency Staffing Plan, pp.2-3.

[3]/ CMS has not publicly stated whether the IT contracts are already issued and funded.

[4]/ The NIH Clinical Center is the agency’s research hospital.

HHS Halts Implementation of the CLASS Program

Recently posted in the National Law Review an article written by Meghan C. O’Connor of von Briesen & Roper, S.C. regarding HSS’ announcement regarding CLASS Act:

The U.S. Department of Health and Human Services (HHS) announced plans today (October 14, 2011) to halt implementation of the Community Living Assistance Services and Supports (CLASS) Act. The CLASS Act is a voluntary, federally administered long-term care insurance program introduced in theAffordable Care Act (ACA). The program would have provided benefits to purchase long-term services and supports. Details regarding implementation and enrollment were to be announced by October 1, 2011.

Secretary Sebelius sent a letter to congressional leaders today noting no “viable path forward for CLASS implementation at this time.” The ACA conditioned implementation of the CLASS program on certification that the program would be actuarially sound and financially solvent for 75 years. However, HHS actuaries and the Congressional Budget Office could not find a way to meet these contingencies

Secretary Sebelius emphasized the continued need for affordable long-term care services and the lack of viable options in the current market.

©2011 von Briesen & Roper, s.c