Monday, August 1, 2011

New drug regulator asks Congress for more power;outsourcing drugs overseas

New drug regulator asks Congress for more power

By Anna Yukhananov

In a June report outlining its new global strategy, the FDA said about half of all medical devices and 40 percent of pharmaceuticals are made abroad, with some 80 percent of the active ingredients in U.S. drugs also manufactured overseas.

WASHINGTON Fri Jul 29, 2011 5:18pm EDT

WASHINGTON (Reuters) - Drug companies should take more responsibility for the safety of ingredients sourced overseas, and Congress should make them if they do not, according to the new U.S. drug regulator for import safety.

The Food and Drug Administration should also have the power to stop medicines at the border if their manufacturers refused FDA inspections, and the power to order mandatory recalls of unsafe products, said Deborah Autor, the agency's newly appointed deputy commissioner.

"People are shocked when they learn that we do not have mandatory recalls (of drugs)," Autor told Reuters in her first interview since she was named head of global compliance earlier this month.

Autor has been making these arguments for at least three years, ever since a contaminant-laced blood thinner, heparin, made its way to the United States from China killing 81 people and sparking lengthy congressional hearings about the FDA's authority.

At the time, Autor was director of the FDA's compliance office, making her directly responsible for unsafe or ineffective drugs.

Since the heparin scandal, she has also overseen the response to a series of massive over-the-counter medicine recalls from healthcare giant Johnson & Johnson and garnered a public service award nomination for cracking down on counterfeit or unapproved prescription medication.

In the newly created role of deputy commissioner for global regulatory operations and policy, Autor will be responsible for similar issues of consumer safety, but with a much larger scope, working to ensure drugs, food and clinical trials from abroad adhere to standards comparable to those in the United States.


Her new office, now a major FDA center alongside medical products and food, is part of the agency's big push in recent years to transform itself into a globally focused regulator that can address the growing amount of imported food and drug ingredients that are consumed in the United States.

In a June report outlining its new global strategy, the FDA said about half of all medical devices and 40 percent of pharmaceuticals are made abroad, with some 80 percent of the active ingredients in U.S. drugs also manufactured overseas.

Between 2007 and 2015, it is estimated that imports of FDA-regulated products will triple, while the agency's inspections budget is unlikely to keep up.

Even at current rates, it would take an estimated nine years for FDA to inspect every high-priority pharmaceutical facility just once, it said.

While the FDA asked Washington for new authority in 2008, the overhaul of U.S. food safety which passed Congress in 2010 did not include provisions about drug safety.

The Food Safety Modernization Act gave the FDA power to order mandatory recalls of food, but drug statutes remained largely the same as they were in 1938.

This time around, Congressional action may be more likely. At a Senate hearing on Thursday, Tom Harkin, the chairman of the influential Health, Education, Labor and Pensions Committee, said one of his policy priorities was "helping to ensure the integrity of our global pharmaceutical supply chain." He will hold hearings on the issue in the fall.

The Committee is likely to give the FDA stronger authority over drugs as part of a broader bill to renew FDA industry fees, which expire next year.

"We've talked about this quite a bit publicly," Autor said. "So I'm glad to see Congress picking it up."


Autor started her public health career as a trial attorney at the Department of Justice, litigating civil and criminal cases on behalf of the FDA, before joining the agency's office of compliance in 2002.

Her top priority when she begins her new job as early as next week is to build more partnerships with global regulatory authorities, especially in Europe, Australia and Canada.

Recognizing that it is impossible for a single country to inspect the world's drug supply, Autor said she will work with counterparts to share information on inspections and make sure medical product facilities and clinical trials run according to "science-based standards."

Like the 60-year-old model for international air traffic control, the FDA wants to create a system of mutually recognized safety regulations.

"This model necessitates mutual reliance, even with countries that have different standards," Autor said. "To me, it matters whether we are comfortable with the outcomes of their systems.

"If I were in Europe, I'd feel comfortable taking European drugs," she said.

Maybe less so drugs from China or India, the major countries for drug manufacturing. Together, in 2007 they housed nearly 70 percent of the world's manufacturing sites for active drug ingredients, up from 49 percent in 2004, according to a report by Pew Health Group, "After Heparin."

Besides heparin, Chinese manufacturers have been linked to a series of consumer product recalls ranging from contaminated pet food to excessive lead in paint that saw millions of toys swept from stores.

"The level of advancement of a local regulatory authority can affect the level of risk associated with a locality's products," Autor said. "But I think bad things can happen anywhere in the world, including here in the U.S.

"We need to look at every link in the supply chain and consider every risk."

(Reporting by Anna Yukhananov; editing by Michele Gershberg and Matthew Lewis)

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