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New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or ... read more

Marketing Tax Provision Escapes Senate Vote

Jan. 13, 2017 – An amendment introduced by Sen. Al Franken (D-Minn.) to eliminate the tax deduction for drug marketing ... read more

FDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion

Jan. 4, 2017 – The FDA will examine whether consumers and health care professionals (HCPs) can identify deceptive claims in ... read more

OPDP Cites Two Companies for YouTube Videos Featuring INDs

Jan. 3, 2017 – In its last blast of 2016, the FDA’s Office of Prescription Drug Promotion (OPDP) sent Untitled ... read more

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

Dec. 15, 2016 – Television ads allegedly making false and misleading claims about the risks associated with their products were ... read more

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Update: Supreme Court Decision Ends Presumption in Favor of “Pay for Delay” Agreements

June 17, 2013 – In a 5-3 decision announced today, the U.S. Supreme Court ended the legal presumption that “pay for delay” agreements among branded and generic drug companies are legal. The decision will allow the Federal Trade Commission to challenge and block these agreements when it finds them to reduce competition from other generic drug companies.

“While not unexpected, this decision effectively will shorten the patent protection period for many drugs, shortening the time a company can recoup its development costs,” said Coalition Executive Director John Kamp. “While at least one major pharma Wall Street analyst has opined that many major patents will be unaffected, the ruling will kill most ‘pay for delay’ agreements.”

The FTC v. Actavis opinion, written by Justice Stephen Breyer, states that the Eleventh Circuit “erred in affirming the dismissal of the FTC’s complaint.

Although the court did not rule on whether “pay for delay” agreements were unlawful on their face, it did find that in this case, the payment from Solvay Pharmaceuticals – maker and patent holder for the testosterone gel, AndroGel – to Actavis represented an unlawful restraint of trade.

For previous coverage of this case, go to: http://www.cohealthcom.org/?p=1525