Drug Companies Are Exploiting This Law to Keep Prices High

Pharmaceutical companies are exploiting a Food and Drug Administration (FDA) policy to undermine competitors and maintain monopolies on their products, The Atlantic’s Sarah Zhang reported Wednesday.

Opioid Pills

Citizen petitions — which were introduced by the FDA in the 1970s to allow individuals to flag concerns about drug safety — are increasingly filed by pharmaceutical companies against competitors who are attempting to sell generic versions of their drugs. By filings these petitions, companies can effectively extend their exclusive hold on a drug beyond the expiration of their patent, as it can often take months for the FDA to respond to a citizen petition.

As the Atlantic noted, “According to a study last year, brand-name pharma companies filed 92 percent of 505(q) citizen petitions, a specific type related to pending generic applications.”

For example, take Mylan Pharmaceuticals, the maker of EpiPen, that was widely rebuked last year for hiking the drug’s price.

In 2015, Mylan submitted a citizen petition against Teva’s generic version of EpiPen, alleging that the generic option failed 93 percent of the time. That conclusion was based on a study that Mylan commissioned, and it was “flawed from start to finish,” according to Diana Zuckerman, the head of the nonprofit FDA monitor National Center for Health Research. […]

Read the full article here.