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Is Drug Safety in the U.S. Moving in the Right Direction?

Protecting the public’s health is an important part of the part of the U.S. Food and Drug Administration (FDA) job. And on May 7, the FDA proposed several measures that would allow the agency to better regulate the safety of Americans’ food and medical products. The FDA request for the President’s fiscal year 2010 budget asks for $3.2 billion to protect and promote public health. This figure, which is a 19 percent increase from the current FDA fiscal year budget, is a significant step towards the direction of a safer pharmaceutical supply chain.

Thomas T. Kubic  Kubic (sm)

Protecting the public’s health is an important part of the part of the U.S. Food and Drug Administration (FDA) job.  And on May 7, the FDA proposed several measures that would allow the agency to better regulate the safety of Americans’ food and medical products.  The FDA request for the President’s fiscal year 2010 budget asks for $3.2 billion to protect and promote public health.  This figure, which is a 19 percent increase from the current FDA fiscal year budget, is a significant step towards the direction of a safer pharmaceutical supply chain. 

If approved, the budget would be directed towards two major pharmaceutical protection goals –Safer Medical Products and Follow-on Biologics & Drug Importation.  The Safer Medical Products proposal will allocate $166.4 million towards safeguarding human and animal drugs, medical devices, vaccines, blood, and other medical products.  This proposal will also establish fees to reinspect medical product facilities, so they will meet safety standards, and also instate a review for generic drugs. 

An additional $5 million will be distributed to the Follow-on Biologics & Drug Importation proposal, which would give the FDA authority to follow biologics through a regulatory path.  While all significant strides, a part of this money will be allocated towards developing policies for Americans to import drugs from foreign countries. 

While a good-intentioned idea, PSM believes that drug importation will only further dilute drug safety.  Following are some questions not addressed in this proposal, including:

  • How will the FDA ensure the safety, security and quality of the drugs being imported to American consumers when foreign regulators do not scrutinize drugs bound for the United States?
  • How will the proposal address the FDA’s lack of qualified inspectors and the gaps in its authority?
  • How will the FDA ensure the safety of ALL drugs imported when the manufacturer’s packing, with security features, is removed by parallel traders in the EU.
  • Without an adequate investigative staff stationed abroad, under the proposed drug importation plans criminals will have even greater opportunities to slip counterfeit drugs into legitimate supply chains.

Today, patients in the U.S. are besieged with Internet ads for unapproved and unsafe medicines – and the FDA is unable to address these problem.  Tomorrow will it be better?  Or, is likely that these drug importation programs will only encourage Americans to gamble with their health.  For more information on the dangers of counterfeit drugs, visit www.safemedicines.org.

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