FDA targets barriers to generic competition
The Food and Drug Administration (FDA) has announced its intention to target the barriers to generic drug competition.
In a blog post on Wednesday, June 21, Scott Gottlieb, the FDA’s managing director, said that although the FDA doesn’t have a direct role in drug pricing, it can take steps to help address the problem.
The FDA will do so by “facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines” through its drug competition action plan.
As part of the effort, the FDA will hold a public meeting on July 18, 2017, to solicit input on places “where FDA’s rules—including the standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended”.
Gottlieb explained that the FDA was aware that sometimes the regulatory rules might be “gamed” in ways that may delay generic drug approvals beyond the time frame the law intended.
An example of the “gaming” is the increasing unavailability of certain branded products for comparative testing.
According to the FDA, to perform the studies undertaken to develop a generic product, the generic sponsor needs between 1,500 and 3,000 doses of the originator drug.
“I understand that generic sponsors are willing to buy these products at fair market value but, in some cases, branded companies may be using regulatory strategies or commercial techniques to deliberately try to block a generic company from getting access to testing samples,” said the blog post.
The FDA will also look at how best to coordinate with the Federal Trade Commission (FTC) in identifying and publicising practices that the FTC finds to be anti-competitive.
“Over the last decade alone, competition from safe and effective generic drugs has saved the health care system about $1.67 trillion,” said Gottlieb.
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