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Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization ... read more

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top ... read more

Industry Groups Oppose Oregon Bill Calling for Advertising Price Disclosure

March 9, 2017 – Four major advertising and media industry groups have issued a joint letter opposing an Oregon bill ... read more

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes ... read more

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February ... read more

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that ... 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