Regulatory Focus™ > News Articles > FDA: Challenge to Enforcement Discretion Without Standing, Merit

FDA: Challenge to Enforcement Discretion Without Standing, Merit

Posted 26 July 2012 | By Alexander Gaffney, RAC 

Are the US Food and Drug Administration's (FDA) discretionary enforcement actions beyond industry reproach? In a recent court filing, lawyers for the US regulators argue they are, especially as discretionary actions-and statements of intended actions-relate to a specific court case filed by Minneapolis-based KV Pharmaceutical.

In a July filing before the US District Court in DC, KV argued FDA had used enforcement discretion to "unlawfully" promote competition to its drug, Makena, in violation of federal law. In seeking redress, it argued FDA's actions were having a pronounced and pernicious effects on its ability to conduct business and faced the likelihood of bankruptcy in the near future without court-ordered intervention.

A Controversial History

To understand the full context of the case, it helps to know the history of KV's drug, Makena (hydroxyprogesterone caproate injection).

In 2011 the company won FDA approval for Makena, also known as 17P, for use in reducing the likelihood of mothers giving birth prematurely. While the compound had long been used by doctors for the same purpose, it had not undergone significant clinical testing to ensure its safety. KV took advantage of the provisions of the Orphan Drug Act to receive market exclusivity, ensuring it would be the only manufacturer able to sell the drug for the given indication.

Controversy soon erupted after the drug won FDA approval when the company announced it would markup the drug's price from approximately $20 per injection to nearly $1,500 per injection. After suffering from withering criticism, the company agreed to drop the price to just $690 per dose and institute a patient assistance program to help patients afford the drug.

FDA meanwhile issued a statement saying pharmaceutical compounders, who traditionally made the drug in hospital settings, would still be allowed to manufacture the drug so long as they did so on a small-scale basis and adhered to quality regulations. Despite KV's protestations to the contrary, FDA affirmed its decision to do so for a second time in June 2012.

Shortly thereafter, KV filed a lawsuit against the agency in the US District Court of Washington, DC, arguing regulators had promoted "unlawful competition" against the company in violation of their exclusive rights to market the drug. The company also took aim at FDA's use of enforcement discretion, saying it was erecting "unlawful barriers to access Makena."

FDA Argues Lack of Standing, Merit

FDA sought to dispel some of KV's arguments in a court filing on 20 July, saying their arguments against their use of enforcement discretion were "unavailable as a matter of law"-in other words, without merit-and was "not likely to redress their inquiry."

"FDA's decision not to take enforcement action are committed to the agency's discretion under Heckler v. Chaney," argues FDA. Further, FDA stated it did not actually carry out any actions under the enforcement discretion, but merely expressed their intent to do so at a future point in time in their statement.

A final argument expressed by the agency notes FDA's own testing of a batch of compounded samples provided by KV to the agency found them to be safe, mitigating any potential health concerns. "[It] would be both inappropriate and contrary to the public interest" to reject FDA's enforcement priorities, FDA concluded.


Read more:

h/t The Pink Sheet - FDA's Nonenforcement Actions Are Not Reviewable, Agency Argues In KV's Makena Suit


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