FDA Faces Internal Changes and Challenges - Pharmaceutical Technology

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FDA Faces Internal Changes and Challenges
Food-safety, transparency, and counterfeit-drug growth will tax agency resources.


Pharmaceutical Technology
Volume 35, Issue 2, pp. 26-30

Fighting fakes

In his position as a key advisor to Commissioner Hamburg, John Taylor heads FDA's emergency, counterterrorism, and crisis-management activities, which involves him in efforts to combat drug counterfeiting and adulteration. In December 2010, Taylor represented the agency at a White House forum on intellectual-property (IP) theft organized by the Office of Intellectual Property Enforcement in the Office of Management and Budget. Attorney General Eric Holder headed a list of top administration officials voicing concern that IP theft has serious economic consequences for firms seeking to market legitimate goods, while also threatening the health and safety of consumers. Holder highlighted Justice Department efforts to step up enforcement of pharmaceutical IP cases, such as the successful prosecution of sellers of fake cancer medications and a conviction in Houston, Texas, for selling counterfeit drugs manufactured in China that contained a substance used to manufacture sheet rock.

Fake medicines appear to be a growing problem. At the White House forum, Tom Kubic, president of the Pharmaceutical Security Institute (PSI), reported on data documenting a 700% increase in counterfeit-drug incidence worldwide from 2002 to 2009. Halting the sale of counterfeit drugs is particularly difficult because it's relatively easy to make these products, explained John Clark, vice-president of global security at Pfizer during the forum. All it takes is a large garage, an air compressor, and some kind of blender, Clark noted. It's more difficult to obtain a good tablet press, he added, but fraudulent operators manage to do that as well.

One strategy for combating distribution of knock-off medicines is to crack down on unregulated online pharmacy websites. The Alliance for Safe Online Pharmacies is tackling this problem, as is a new nonprofit organization targeting illegal Internet pharmacies. The coalition is supported by leading Internet commerce companies, such as Google, Microsoft, Yahoo!, MasterCard, Visa, and American Express, and will establish and maintain a registry of legitimate online pharmacies as one way to distinguish them from unethical operators.

One aim of the White House meeting was to build support in the business community for an Anti-Counterfeiting Trade Agreement (ACTA) that is being negotiated with the European Union, Japan, Canada, Switzerland, and other industrialized nations. Even though counterfeit drugs are a growing problem at home, the US situation pales in comparison to the spread of fake medicines in developing nations. As much as 25% of the global drug market may be counterfeit, according to the World Health Organization, and sales of phony medicines add up to some $75 billion per year. Despite objections that the pact might stymie access to lower-cost generic drugs and biosimilars, a final agreement is expected this year.

A primary challenge in blocking counterfeit drugs is to convince the public that knock-off products that appear similar to genuine drugs may be unsafe or ineffective. "Many consumers don't take this as a serious threat to public health," observed Carmen Catizone, president of the National Association of Boards of Pharmacies. No one will take action until "they see dead bodies," he said.

This situation, however, may change as evidence emerges of more fatalities linked to counterfeit drugs. Widely prevalent counterfeit malaria treatments have been implicated in the deaths of thousands of people abroad. Taylor cited a rise in seizures among epilepsy patients, which turned out were related to a counterfeit active ingredient in a widely used treatment. "We see our job as preventing death and harm," Taylor explained during the White House forum. Yet, he noted that alerting the public to the dangers of counterfeit medicines raises the prospect that some patients may get nervous and stop legitimate treatment.

To ensure the safety of imports and drug-supply lines, FDA is developing a risk-ranking system for imported active pharmaceutical ingredients to target more risky products for additional sampling and testing at borders. The agency also is establishing standards for track-and-trace systems that can distinguish genuine from counterfeit products. An internal Counterfeit Working Group is coordinating anticounterfeiting efforts across the agency, while CDER has established a Drug Integrity and Security Program in its Office of Compliance to focus on counterfeiting, diversion, cargo theft, and other supply-chain threats.

FDA may enhance its oversight of global drug manufacturing further through its new membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) (see page 83 for full story). The decision to admit FDA to the coalition, which became effective last month, comes just in time for Commissioner Hamburg to deliver a keynote address to a symposium in Geneva next May celebrating PIC/S's 40th anniversary.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,
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