Senator Collins Raises Concerns to Top FDA Official Regarding Accessibility and Pricing of Rx Drugs

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Washington, D.C.— At a Senate hearing this morning, U.S. Senator Susan Collins questioned a top FDA official, Dr. Janet Woodcock, on the FDA’s work to expedite generic drug applications in order to make prescription drugs more affordable for consumers.  Increasing market competition by accelerating the approval process for generic drugs has been identified as a potential way to combat the egregious price hikes of certain decades-old prescription drugs, a problem that the Senate Aging Committee is currently investigating.  In response to Senator Collins’ questions, Dr. Woodcock indicated she would be happy to work to together on this serious issue.

Senator Collins began her questioning by highlighting the Aging Committee’s ongoing bipartisan investigation, “into the sudden, very aggressive price spikes that some companies have implemented on drugs that have been on the market for literally decades.”

She continued, telling Dr. Woodcock that “one of things I would like to work with you on is whether there is a way to eliminate the incentive by having this expedited approval that would encourage a generic to come in, and discourage the company from buying up the decades-old drug thinking it is going to have a monopoly long enough to make a great deal of money…What we are finding is that a lot of these companies are not doing the manufacturing.  It is a new business model, and I am convinced that it is one that is negative for patients, providers, hospitals, and federal and state health care programs.”

On November 4, 2015, the Senate Aging Committee opened a bipartisan investigation into these dramatic price hikes for certain off-patent drugs.  The Committee held the first in a series of hearings, titled “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines,” on December 9, 2015.

Senator Collins is the Chairman of the Senate Aging Committee and a senior member of the Health, Education, Labor, and Pensions (HELP) Committee.