Senator Patrick Leahy wrote a letter asking Food and Drug Administration (FDA) Commissioner Scott Gottlieb to do something about the practices some brand-name pharmaceutical companies, ensuring the companies do not solely control the market.
Current regulations require generic companies to test their drugs against the brand-name equivalents and work with the brand-name companies to create a safety plan before their drug can be approved for the market.
However, some brand-name companies delay sending the samples and information generic companies need, so the brand-name drug remains the only drug on the market, allowing brand-name companies control the prices, according to an outline of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
According to a release from Leahy’s Office, the letter will be considered alongside information from the FDA’s public meeting on Tuesday entitled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.“
In his opening remarks at the meeting, Gottlieb expressed concerns about the practices of some pharmaceutical companies saying, “In some cases, we know that branded companies are using our rules that are intended to protect consumers, or meant to make the regulatory process more predictable, and taking advantage of these rules in order to deliberately forestall the entry of expected generic drug competition. In other words, they are ‘gaming’ our system.”
In the letter, Leahy and three other senators discuss how the FDA could maintain safe practices while avoiding delays from competing companies. They also talk about how the bipartisan CREATES Act could help solve the issue.