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FDA Unveils List of Companies “Gaming the System”


May 2018

FDA Unveils List of Companies “Gaming the System”?

The U.S. Food and Drug Administration (FDA) recently released a list of 40 pharmaceutical companies believed to be using “gaming tactics” to slow down the drug development process for the purpose of curbing generic drug competition. Delaying market availability of generic drugs provides pharmaceutical companies with additional profits at the expense of affordable alternatives for patients. The release of this list —which has since been coined the “FDA Shame List”— has inserted the FDA into the hotly contested debate on U.S. drug prices.

“One of the primary ways that FDA facilitates a competitive marketplace is through the efficient approval of generic drugs, which are often lower-cost than brand drugs,” explains the FDA on its website.

“Unfortunately, the process established by Congress may not always function as intended. At times, certain ‘gaming’ tactics have been used to delay generic competition. 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 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.”

Next to each offending company, the FDA includes the number of inquiries it has received from generic companies looking to obtain drug samples, a required part of the generic development process. Companies topping the list include Celgene, Actelion Pharmaceuticals, Pfizer, Gilead Sciences, Novartis Pharmaceuticals and more.

Since becoming commissioner, Dr. Gottlieb has made it his mission to lower drug prices in the U.S. and make it easier for generic competitors to enter the market. He’s also made it clear that he holds big pharma companies accountable for the country’s escalating drug costs.

Pharmaceutical companies defend their position by saying they spend billions of dollars on research and development, and require robust patent protection to continue to develop and manufacture new drugs.

This ongoing pricing debate is one that, until now, the FDA steered clear of, as the companies listed have technically not violated any standard. So, whether you agree with Dr. Gottlieb or not, the question now becomes: is it right or ethical for the FDA to publicly “shame” big pharma companies?