FDA Failed to Track Substandard Generics, Congress Told

The Food and Drug Administration has failed to monitor the effectiveness of generics that make up 80 percent of medicines sold in the U.S., according to doctors and researchers who said new regulatory efforts aren’t enough.

Generic heart drugs made by some India-based companies don’t work as they should, said Preston Mason, a researcher at Brigham & Women’s Hospital in Boston who has studied the effectiveness of copies of Pfizer Inc.’s Lipitor made in the U.S. and abroad. That may be because some companies are cutting corners to save money, he said.

“This is the Wild West, the whole generics business,” Mason said yesterday during a briefing in Washington that included about 50 congressional staffers and representatives from the White House, the State Department and the FDA.

Mason’s research included 36 different copies of the Lipitor cholesterol pill collected from 15 countries, he said. Generic versions from U.S.-based companies Mylan Inc. and Actavis Plc weren’t contaminated, the study found. The FDA last week said it was reviewing the results.

Many of the drugs Mason studied “at best didn’t work, and at worst may have had adverse affects on the body,” he said at yesterday’s briefing. The meeting at the Capitol was organized at the request of the speakers to educate lawmakers in hopes of moving toward formal congressional hearings on the topic.

FDA Actions

The FDA has begun a $20 million generic-drug testing effort working with academic centers, Bloomberg News reported last week. At the same time, Commissioner Margaret Hamburg said during a visit to India this month that the FDA will increase the number of plant inspections it does there. Several speakers at the briefing said these steps, along with a training program for government regulators in India, aren’t enough to ensure that copycat medicines used in the U.S. are safe.

Speakers urging formal congressional hearings included Amir Attaran, a law professor at the University of Ottawa, and Dinesh Thakur, a former executive at Gurgaon, India-based Ranbaxy Laboratories Ltd. Thakur was a whistle-blower in allegations Ranbaxy didn’t provide proper data on drug testing, charges settled by a guilty plea in May.

In 2012, the U.S. Congress gave the FDA the authority to collect fees from the generics industry, in part, to increase inspections overseas.

Still, Attaran said, “we need more eyes on this in Congress. The rules in this country leave the doors too wide open to medicines in question.” He suggested the FDA focus on the capacity of foreign regulators to meet U.S. standards rather than inspecting as many facilities as possible.

Senate Hearing

Senators on the Health, Education, Labor and Pensions Committee may discuss drug quality at an FDA oversight hearing in the next couple months, according to a staff member who wasn’t authorized to speak publicly on the issue.

Roger Bate, a researcher on international health policy at the Washington-based American Enterprise Institute, questioned whether more inspections are the best path, or whether doctors and patients should be given more information on where drugs and the ingredients come from so they can offer their own judgment by refusing to use certain products.

The FDA has banned four plants in India over the past nine months from exporting generic drugs to the U.S. It’s a country, Bate said, that’s making “an amazing array of products. This should be, and I think is, an increasing concern for all of us.”

Domestic Overview

Bate also asked whether the agency should direct more resources to spot-check products in the U.S.. Bate and Attaran, the University of Ottawa professor, run Searching for Safety, a website that compiles articles, research and data on fake and substandard drugs and advocates for ways to avoid them.

After the briefing, FDA spokesman Christopher Kelly said the agency’s India office has “been working closely with India’s drug regulators to reinforce the importance of producing quality products for patients. FDA believes strongly in the importance of expanded lines of communication and collaboration with India’s drug regulators to ensure quality products.”

Mason’s study on generic versions of the cholesterol drug Lipitor, published last year, largely found impurities in copies of the medicines produced abroad, rather than in the U.S. Those impurities, which sometimes rendered the treatments ineffective, occur during manufacturing and weren’t being removed before the drugs were exported, he said at the briefing.

“It’s something that has to be addressed if you want to make a drug properly,” Mason said.

Harry Lever, a cardiologist at the Cleveland Clinic, also spoke, saying patients who have failed to respond to generic drugs produced abroad do much better after he switches them to copycats from the U.S., or to branded medicines.

Problems with generic effectiveness aren’t “generally known in the cardiology community,” Lever said. “If you talk to individual cardiologists about this they’ll say ‘Yeah, I had a few patients that this didn’t work.’”

“No offense, but you kind of scared the hell out of me,” said Lisa Gregory, a state department fellow working in the office of Representative Tulsi Gabbard, a Democrat from Hawaii.

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