McKinley, Welch Introduce Bipartisan Bill to Lower Prescription Drug Prices

REMEDY Act Will Help End Anticompetitive Patent Abuse

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Washington, July 18, 2019 | comments
Representatives David B. McKinley, P.E. (W.Va.-1) and Peter Welch (Vt.) introduced H.R.3812 the Reforming Ever-greening and Manipulation that Extends Drug Years (REMEDY) Act which will help to reduce the cost of prescription medicine by helping to end patent abuses that prevent generic drugs from entering the market.

The REMEDY Act would amend a Food and Drug Administration (FDA) statute which provides monopoly extensions and incentivizes brand manufacturers to manipulate the system by filing numerous additional patents on their product in an attempt to prevent generic competition.  Under the REMEDY Act, there would be fewer incentives for excessive patents, and allowing generic alternatives to enter the market without facing frivolous litigation.

“For too long drug companies have used the patent system to discourage competition and reap profits,” McKinley said. “The REMEDY Act will save consumers billions of dollars by increasing competition. Families should never have to decide between affording their medications and grocery shopping or filling up their gas tanks.” 

“Americans are getting hammered by skyrocketing drug prices kept artificially high by a lack of competition,” Welch said. “This bill will crack down on yet another anticompetitive practice that drug companies use to unfairly keep generic drugs from the market and keep prescription drug prices high.  Cutting down on these abuses will save consumers money and make important drugs more accessible to families struggling to make ends meet.”

Senators Dick Durbin (D-Ill.) and Bill Cassidy, M.D. (R-La.), introduced the senate companion to the REMEDY Act in April. McKinley and Welch have previously introduced H.R. 985 Fair Access for Safe and Timely (FAST) Generics Act and are both original cosponsored the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act which recently passed the House of Representatives.

Background:

Pharmaceutical manufacturers are required by the Food and Drug Administration (FDA) to list all their patents covering a drug in the FDA’s Orange Book. When a generic drug manufacturer submits a drug for approval to the FDA, the generic may be forced to challenge the validity of the existing patent in the Orange Book.  When that happens, there is automatically a 30-month delay of FDA approval for the generic. The stay is automatically applied regardless of how weak a brand manufacturer’s patent claims on a drug may be.  


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