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Plans to root out fake, substandard meds at both ends of Pennsylvania Ave

Posted by Jean Silver-Isenstadt, MD, PhD, NPA Executive Director March 22, 2011 at 12:01 PM

Cross posted with permission from PostScript, a blog from Community Catalyst

Major chemical-makers have told FDA they’ll chip in to make sure foreign ingredient factories get inspected, and in the Capitol such a cooperative spirit to tighten up security and oversight in the prescription and over-the-counter drug supply is growing.

Last week the White House named 20 anti-counterfeiting measures it urges Congress to take, many of which are geared toward to counterfeit or knowingly contaminated medicines. And within the last week several House and Senate committees have pledged to further investigate ways to prevent fake, unsafe and substandard drugs from getting into US pharmacies and medicine cabinets.

Among the White House proposals are:

  • Require importers and manufacturers to notify the FDA and other relevant agencies when they discover counterfeit drugs, including the known potential health risks;
  • Adopt a track-and-trace system for pharmaceuticals and related products;
  • Provide civil and criminal forfeiture under the Federal Food, Drug and Cosmetic Act (FFDCA), particularly for counterfeit drug offenses;
  • Increase the statutory maximum for drug offenses under the FFDCA, particularly for counterfeit drug offenses; and
  • Recommend that the U.S. Sentencing Commission increase the Guideline range for intellectual property offenses that risk death and serious bodily injury, and for those offenses involving counterfeit drugs (even when those offenses do not present that risk).

It’s key that the White House and Congress are talking about drug safety as an issue of national security, for it undoubtedly is: Ensuring that the nation’s drugs are made in sanitary facilities with materials that have been vetted and verified for safety and quality is an issue of both public health and economic security.

At the ‘After Heparin’ conference last week, regulators and legislators agreed that big overhauls are required to catch the safety system up with the pace of overseas manufacture and supply. The FDA laid out a global supply chain security plan that moves the agency toward more frequent coordinated inspections, information-sharing, targeted intelligence and overseas partnerships. And Sen. Michael Bennet pledged to expand his bill drug safety bill and secure bipartisan backing for it.

Congress is right to be vigilant and active on these issues, Thomas Kubic of the Pharmaceutical Security Institute wrote this week in an op-ed in The Hill, since theft and other breaches in the supply chain ultimately leave patients at risk :

[T]he second any drug leaves the carefully controlled and policed supply chain, it becomes nearly impossible for anyone to know where it’s been stored, how it’s been handled and whether or not it’s become contaminated. And this presents a health risk to anybody who takes any type of medicine.

All this means that the United States cannot let its guard down when it comes to securing the drug supply here at home…Even in a divided political environment, it’s a commonsense public safety step everyone should be able to support.

By Kate Petersen, from PostScript

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