Lawmakers question FDA oversight of P.R. plants

Does the FDA have a weak link? The House Committee on Oversight and Government Reform is asking the agency whether its office in Puerto Rico has been understaffed and under-performing, given recent drug-manufacturing problems found on the island.

Sent by Reps. Edolphus Towns and Darrell Issa, the letter points out the ongoing problems with drugs made at a Johnson & Johnson ($JNJ) plant that manufactured consumer drugs subject to a series of recalls. And it raises questions about serious manufacturing shortfalls at a GlaxoSmithKline ($GSK) plant; the company recently agreed to pay $750 million to settle claims involving substandard manufacturing there.

Puerto Rican facilities were also involved in Pfizer's ($PFE) recent recalls of moldy-smelling Lipitor. Bristol-Myers Squibb ($BMS) has had ongoing problems at a facility in Manati, in-Pharma Technologist points out. And, according to Bloomberg, drug plants on the island failed their FDA inspections 64 percent of the time from 1999 to 2010--and 70 percent of the time since 2007.

So, the committee is asking for FDA documents, including a list of the Puerto Rican sites overseen by the agency, a list of its inspections performed over the past 10 years, and copies of warning letters issued for Puerto Rican facilities. "It appears that FDA's Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," Issa and Towns wrote. The FDA says it will respond when it receives the letter.

- see the New York Times coverage
- get more from Bloomberg
- see the in-Pharma Technologist story

Suggested Articles

The FDA has granted Amarin's Vascepa a possible blockbuster label expansion for CV risk reduction in patients with or without CV disease.

In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. 

It’s been a year of ups and downs for Pfizer’s Xeljanz. But the company is hoping to close on a high note, with help from a new extended-release pill.