Franklin Gray and White Blog

Officials Concerned With Drugs Produced Abroad

From the New York Times:

"In 2004, when Bristol-Myers Squibb said it would close its factory in East Syracuse, N.Y. — the last plant in the United States to manufacture the key ingredients for crucial antibiotics like penicillin — few people worried about the consequences for national security.

“The focus at the time was primarily on job losses in Syracuse,” said Rebecca Goldsmith, a company spokeswoman.

But now experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States.

“The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism,” said Senator Sherrod Brown, Democrat of Ohio, who has held hearings on the issue.

Decades ago, most pills consumed in the United States were made here. But like other manufacturing operations, drug plants have been moving to Asia because labor, construction, regulatory and environmental costs are lower there.

The critical ingredients for most antibiotics are now made almost exclusively in China and India. The same is true for dozens of other crucial medicines, including the popular allergy medicine prednisone; metformin, for diabetes; and amlodipine, for high blood pressure.

Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the Food and Drug Administration in 2007, only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India.

Some of these medicines are lifesaving, and health care in the United States depends on them. Half of all Americans take a prescription medicine every day.

Penicillin, a crucial building block for two classes of antibiotics, tells the story of the shifting pharmaceutical marketplace. Industrial-scale production of penicillin was developed by an American military research group in World War II, and nearly every major drug manufacturer once made it in plants scattered throughout the country.

But beginning in the 1980s, the Chinese government invested huge sums in penicillin fermenters, “disrupting prices around the globe and forcing most Western producers from the market,” said Enrico Polastro, a Belgian drug industry consultant who is an expert in antibiotics.

Part of the reason these plants went overseas is that the F.D.A. inspects domestic plants far more often than foreign ones, making production more expensive in the United States.

“U.S. companies are more regulated and are under more scrutiny than foreign producers, particularly those from emerging countries. And that’s just totally backwards,” said Joe Acker, president of the Synthetic Organic Chemical Manufacturers Association. “We need a level playing field.”

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