Ned Sharpless, the Commissioner of the Food and Drug Administration (FDA), has just announced that the agency will be taking steps to improve the development and approval process of high-quality generic drugs in the US.
Generic drugs make up an estimated 90% of all prescriptions. And, being generally a lot cheaper than branded alternatives, Sharpless said that, in the coming years, greater efforts will be placed on promoting more competition between manufacturers in order to bring the prices down for patients being issued prescriptions.
This follows the previous Commissioner, Dr. Scott Gottlieb’s, attempts to bring cheaper prescription drugs into the marketplace. He argued that by speeding up the development of new generic brands, consumers could benefit from lower prices.
However, the FDA has accused drug manufacturers of blocking these developments in order to stop competitors from creating cheaper versions of generic drugs. This “gaming tactic” has, according to the FDA, caused prices to remain high.
Whilst still in office, Gottlieb commented on this, noting that there was a backlog of close to 4000 applications for new generic drugs. There were delays in approving numerous drugs including naloxone, valsartan, and narcan.
In a statement, the FDA said: “One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug.”
“The inability of generic drug companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process — leading to delays in bringing affordable generic alternatives to patients in need.”
Sharpless said that reducing the time for new applications to be approved is vital in enhancing efficiency, and for getting the best results for consumers. He also said it needs to be made easier to applications to challenge patents.
“We also are striving to provide the industry with greater transparency in order to provide greater certainty around timing of market entry and empower more informed decisions on how to prioritize their resources,” Sharpless said.