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Regulatory News | 21 June 2017 | By Michael Mezher
As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition.
"We know that sometimes our regulatory rules might be 'gamed' in ways that may delay generic drug approvals beyond the time frame the law intended," FDA Commissioner Scott Gottlieb said, just days after FDA released new draft guidance on priority reviews for generic drugs.
In July, FDA will host a public meeting to gather insight on some of these practices, which include risk evaluation and mitigation strategy (REMS) abuse, restricted distribution agreements, patent listing practices and citizen petitions.
The meeting is a first step towards Gottlieb's previously announced drug competition action plan, which he says will be fleshed out in the future as additional components are unveiled. Gottlieb also says FDA is looking to improve its coordination with the Federal Trade Commission to crack down on anti-competitive practices.
At the meeting, FDA will seek input on other areas where generic competition has faltered.
For instance, the agency says it has not received an abbreviated new drug application (ANDA) for roughly 10% of off-patent innovator drugs, and more than half of the generics it has approved are either never marketed or face substantial delays before being marketed.
As such, FDA says it wants to know whether there are market forces that do not incentivize generic competition, or whether the regulatory incentives for developing certain generics are insufficient, and what it could do to foster competition in these areas.
The announcement comes as President Donald Trump may issue an executive order on drug prices, though critics say draft documents from a meeting with senior administration officials last week look more like a pharmaceutical industry wish-list.
While FDA does not have authority over drug prices, the introduction of generics, especially when there are multiple competitors for a single reference product, can lead to significant savings.
Between 2005 and 2014, FDA says generics led to $1.68 trillion in savings, citing research conducted by QuintilesIMS.
However, Gottlieb says the US could see even greater savings if generics were able to get to the market more efficiently once patents and marketing exclusivity periods expire.
FDA Voice, Federal Register
Tags: REMS, Competition, Generic Drugs