Former FDA Chief Backs Clinton's Push for Daraprim Competition

  • David Kessler served as FDA commissioner in the 1990s
  • Kessler says FDA could approach drugmakers with expertise

A former commissioner of the Food and Drug Administration backed Democratic presidential candidate Hillary Clinton’s push for low-cost competition for an antiparasitic medication after a pharmaceutical company bought the drug and raised its price more than 50-fold.

The drug, Daraprim, has been at the center of a political debate over U.S. drug prices and its maker, Turing Pharmaceuticals AG, has been held up as a bad actor by Clinton. Clinton wrote the FDA on Monday asking regulators to “do everything in your power consistent with the safety and efficacy of our drugs to bring lower-cost generics to American consumers more quickly and affordably.”

She cited the FDA’s power to import medicine from abroad -- where cheaper versions of Daraprim are available -- in cases of drug shortages, and that Turing’s high price for the drug of $750 a pill had essentially created such a shortage.

David Kessler, FDA commissioner in the 1990s, called for more competition for Daraprim, without necessarily endorsing what Clinton proposed.

“There’s no doubt that price can be a very significant impediment,” said Kessler, who’s now a professor at the University of California at San Francisco and consults for the Clinton campaign. “When price becomes too great and people can’t have access, then FDA certainly has the ability to expedite the approval of the drugs.”

Kessler also sits on the board of drug manufacturers, including Tokai Pharmaceuticals Inc., and advises the private equity firm TPG Capital Management. After being appointed by former President George H. W. Bush in 1990, Kessler ran the FDA under Clinton’s husband, former President Bill Clinton.

Kessler said the FDA’s first step would be to reach out to companies with expertise in similar drugs. GlaxoSmithKline Plc sells Daraprim in the U.K. Jenni Ligday, a spokeswoman for Glaxo, said the company hasn’t been contacted about the drug.

The FDA has said it plans to respond to Clinton directly. Turing and other drugmakers have said they have programs to help patients afford their drugs, limiting out-of-pocket costs.

FDA Oversight

While importation is one way to address access, “it’s always better to have the FDA review the application and review the safety and efficacy of the drug,” Kessler said.

The FDA has acted previously to maintain access to a drug after a pharmaceutical company raised the price considerably. The agency approved Makena in 2011, made by what was then called KV Pharmaceuticals, to reduce the risk of preterm births. KV priced Makena at $1,500 an injection, and then warned pharmacies to quit making their own versions that costs $10 to $20 an injection.

The FDA allowed pharmacies to continue to make unapproved versions of Makena to support access, though it did test many of them for potency and purity.

Before it's here, it's on the Bloomberg Terminal.
LEARN MORE