Mylan Critic Blumenthal Asks FDA to Help End EpiPen Shortage

(Bloomberg) -- U.S. Senator Richard Blumenthal, who criticized Mylan NV for jacking up the price of its EpiPen allergy shot two years ago, called on federal officials to help end what he called an urgent and alarming shortage of the life-saving device.

In a letter to Food and Drug Administration Commissioner Scott Gottlieb on Monday, the Connecticut Democrat said the agency should work closely with manufacturers and distributors to eliminate shortages of EpiPen and other epinephrine auto-injectors. The FDA said May 9 that while the EpiPen was still available, delays at Pfizer Inc.’s Meridian Medical Technologies, which manufactures the device for Mylan, had led to “intermittent supply constraints.”

Blumenthal requested that the FDA detail what steps it’s taken to alleviate supply delays, when the agency was made aware of the problem and why a notice wasn’t published to its database of drug shortages until May 9.

“Despite assurances from FDA and manufacturers that shortages are intermittent or isolated, there is solid evidence of widespread unavailability,” the senator said.

A Mylan spokeswoman referred back to the company’s May 9 statement, which said the EpiPen “is available and Mylan is currently receiving continual supply” from Meridan. The statement acknowledged that “supply levels may vary across wholesalers and pharmacies” and encouraged patients to call its customer-relations line for help locating alternative pharmacies.

A spokesman for Pfizer said shipments have been increasing over the past few months,

A spokeswoman for the FDA said the agency has received Blumenthal’s letter and will respond directly to the senator.

400 Patients

Last week, Bloomberg News reported that the advocacy group Food Allergy Research & Education found that more than 400 patients in 45 states were having difficulties tracking down the EpiPen shot and similar epinephrine auto-injectors used in emergencies. Some patients had told the group that they hadn’t been able to obtain the devices at all, while others were told they’d have to wait weeks to get one.

This isn’t the first time Blumenthal has criticized Mylan. In October 2016, he said the drugmaker’s $465 million settlement with the U.S. Department of Justice on Medicaid rebates for the EpiPen was a “sweetheart deal” and called for a criminal investigation. When the EpiPen’s price was raised to $600 for a two-pack from about $50, Blumenthal was among the senators who sent Mylan a letter criticizing the lifesaving auto-injector’s affordability.

“In recent years, EpiPen prices have skyrocketed exorbitantly, making them widely unaffordable,” Blumenthal said in the letter Monday. “Now, supply delays and shortages are again denying access to this greatly important device.”

The FDA places drugs on its shortage list when the supply of all versions of a treatment are inadequate to meet current or projected demand, and manufacturers are required to report possible shortages to the agency.

Mylan said patients having trouble locating the injectors should call its customer-relations line at (800) 796-9526.

--With assistance from Anna Edney

To contact the reporter on this story: Emma Ockerman in New York at eockerman@bloomberg.net.

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet

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