Senator Collins Raises Concern about Skyrocketing Price of Off-Patent Drugs with FDA Director at Senate Hearing

Delays of generic drug applications cost consumers an estimated $5.4 billion annually

Click HERE to watch Senator Collins’ Q&A with Dr. Woodcock

Washington, D.C. - At a Health, Education, Labor and Pensions Committee hearing, U.S. Senator Susan Collins (R-ME), a member of the Committee, questioned Dr. Janet Woodcock, the Director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research about the dramatic price increases of certain off-patent prescription drugs. Senator Collins, the Chairman of the Senate Aging Committee, led a bipartisan investigation into the causes, impacts, and potential solutions to these egregious price spikes last year with Senator Claire McCaskill (D-MO).

One of the issues Senators Collins and McCaskill identified was the restricted distribution programs, such as the Risk Evaluation & Mitigation Strategies (REMS) system, that were intended to be pro-consumer but are being abused to delay generic entry into the marketplace.

Earlier this year, Senators Collins and McCaskill reintroduced the Increasing Competition in Pharmaceuticals Act, which would ensure that a clear process is in place for FDA to prioritize the review of generic drug applications. By authorizing a priority review framework for generic applications and increasing transparency in the review process, the Increasing Competition in Pharmaceuticals Act would help increase competition to lower prices and avoid monopolies as well as deter practices that can lead to exorbitant price hikes on drugs that were previously affordable to patients for decades.

“We’ve talked before about the REMS system that has been used by some drug companies to prevent potential generic competitors from getting access to the drug so that they can conduct the bioequivalence studies that you require,” said Senator Collins. “What can be done to ensure that these restrictive distribution programs, which were enacted with the best of intentions, are not abused and are a source of delay for generics coming to the marketplace?”

“We send [the FTC] information when this happens—we’ve actually sent about 150 different settings about drugs over to them regarding this,” Dr. Woodcock responded. “When there is a restricted distribution system, and Congress had said in the original FDA Amendments Act that there has to be a single shared system unless there were good reasons not to, which means the innovator would have to have a shared system of distribution with its competitors. This has delayed availability of generics a very long time in some cases, and that’s something we can’t do too much about. That’s a standing law on the books; it says there should be a single shared system. In some cases we’ve had to go to separate systems that talk to each other so that the generics actually can come onto the market.”

At the conclusion of her exchange with Dr. Woodcock, Senator Collins expressed her hope that the Increasing Competition in Pharmaceuticals Act will be considered as part of the upcoming markup.

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