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, firstname.lastname@example.org