FDA Is More Bark than Bite on Foreign Drug Imports, Seeks More Authority

by U.S. Medicine

November 1, 2011

WASHINGTON — FDA needs the authority to keep foreign manufacturers who do not comply with regulatory requests from importing their products into the United States, agency officials are telling legislators.

Currently, the agency can stop products from entering the country only if they document they are unsafe, which places the burden of proof on FDA, rather than on manufacturers to show compliance.

Until the agency has this kind of power, its regulatory authority in this area will be more bark than bite, and foreign manufacturers will have fewer reasons than domestic ones to follow regulations, according to FDA officials.

Recent Failures

About 80% of active ingredients found in U.S. pharmaceutical products are imported from abroad, and about 40% of finished drugs on U.S. shelves are manufactured in other countries.

“According to FDA, this trend is projected to continue and increase, with more and more of our medicine cabinets being stocked with products from countries like India and China with less robust regulatory systems than our own,” explained Sen. Tom Harkin, D-IA, at a recent Senate Health Committee Hearing. “Our challenge is to embrace the promise of this increasingly global economy while still making sure we protect American patients.”

The difficulties in policing an international drug pipeline have been highlighted by failures in recent years. In 2007, 150 U.S. patients died after taking contaminated heparin. The contamination of the blood thinner was traced to a manufacturer in China in charge of making the active ingredient in the drug.

Drug theft aautor photo.jpglso has been a major problem. In 2009, 46 drug cargo thefts occurred, totaling $184 million. In March 2010, thieves broke into a warehouse and stole $75 million worth of prescription drug products, including chemotherapy agents, antidepressants and blood-thinners, which were never recovered and might have been distributed. In 2009, stolen insulin, which had lost its potency because of improper storage, was reintroduced into the drug supply, causing adverse events in patients. Counterfeit drugs also have made their way to market, including thousands of bottles of counterfeit Lipitor.

“These are some of the enormous challenges that globalization presents to FDA, pharmaceutical manufacturers, and the American public,” explained Deborah Autor, JD, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy. “At every stage of the manufacturing process there are opportunities for the drug to be contaminated, diverted, counterfeited or adulterated.”

FDA Is More Bark than Bite on Foreign Drug Imports, Seeks More Authority Cont.

Authority to Stop Importation

The position Autor fills was created this past July with the express purpose of overseeing FDA’s international regulatory efforts and helping the agency get a handle on the global drug pipeline. She told legislators last month that one of the keys to doing this is for Congress to make FDA less of a paper tiger when it comes to exerting is authority abroad.

“One authority that would be very useful is the ability of FDA to refuse to import products from foreign facilities that have denied FDA officials [access] to come in and inspect them,” Autor said. “It seems common sense that if a company is not a good enough player to let the agency in, those are not the products we want to come to the American consumer. Currently, the law is not clear on that.”

The law currently places the burden on FDA to show something is wrong with the product before it can take the step of barring importation.

“With every other grown-up country that we know of, the regulator has the authority to say, ‘If you want your product to come in, you have to show that it’s good,’” Autor said. “For us, we have to show that it’s bad.”

This means FDA must conduct regular inspections of foreign plants, or arrange for that country’s regulatory officials to do so, and that documentation of the drug be available from the ingredient state to raw processing to distribution. Creating this documentation is very difficult in the current environment, especially in countries that do not have a strong regulatory system of their own, Autor said.

FDA has 13 posts around the world, enabling the agency to do some inspections as well as collaborate with their foreign counterparts. It is unrealistic, however, to expect FDA to be able to inspect every foreign plant necessary with the number of personnel in those countries, according to Autor, who pointed out that  bringing in inspectors from the United States. is not always viable.

For example, in China, while staff from FDA’s China office can freely inspect companies, FDA inspectors need a letter of invitation from the company before they can enter the country and inspect. This makes performing an unannounced inspection almost impossible.

FDA is looking for at least a minimum burden on foreign manufacturers to show the product has been approved and manufactured according to U.S. regulations, Autor said. “This would level the playing field between manufacturers who want to do it right and those that don’t.”

Full Committee Hearing – Securing the Pharmaceutical Supply Chain

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