The National Law Forum

The Blog of the The National Law Review

Category Archives: Drug & Cosmetic Law

Oklahoma and Nebraska Challenge Colorado’s Amendment 64: Legalized Marijuana

In 2012, Colorado was the first state to legalize recreational marijuana with Amendment 64.  While this has made Pizza Franchisors happy and sent snack sales through the roof, it has also created controversy and unintended consequences.  The entire country has watched Colorado sort through these issues, curious to see how things will land, how much …

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Reclassification of Hydrocodone Takes Effect This Week

The U.S. Drug Enforcement Administration (“DEA”) published a Final Rule on August 22, 2014, which elevates hydrocodone-combination products (“HCPs”) to a Schedule II category of drugs under the Controlled Substances Act. That rule becomes effective this week – on October 6, 2014. While some hydrocodone products are already listed as Schedule II, some combination products …

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First Written Decision Pertaining to Pharmaceuticals

Practitioners monitoring the use of inter partes review (IPR) proceedings to challenge pharmaceutical patents may want to note what appears to be a pair of first-time events.  The Patent Trial and Appeal Board (PTAB) recently issued the first Final Written Decision in an IPR proceeding involving a pharmaceutical-related patent. In addition, the first petition for covered business …

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Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device Manufacturers

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers — Internet/Social Media Platforms: Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices (“Guidance on Correcting Third Party Misinterpretation”), and Internet/Social Media Platforms with Character Space …

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Healthcare Fraud Case Results in $491 Million Settlement

On July 30, 2013, Pfizer Inc., one of the world’s largest pharmaceutical companies, announced its finalized agreement to pay $491 million to the U.S. government in order to resolve accusations that the company and one of its subsidiaries defrauded the U.S. healthcare system.  Under the settlement, Pfizer will pay $257 million in order to resolve …

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