PHARMACY

Congress should mull over options before implementing track-and-trace system

BY Rob Eder

WHAT IT MEANS AND WHY IT’S IMPORTANT — It’s about time lawmakers start to understand the real threats posed by drug reimportation and unlicensed Internet pharmacy sites. About 20% of the current members of Congress are newly elected, and there is this recurring, cyclical fascination among politicians that we can fix everything with drug reimportation. But mandating electronic track and trace right now is a bad idea.

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In all, many of the proposals that came out of the joint report delivered this week to Vice President Biden and Congress are good ones:

  • Drug manufacturers and wholesalers should share intelligence with FDA, Customs, the DEA and every other relevant agency involved in guarding the nation’s pharmaceutical supply chain. Such companies as Pfizer, which was featured in a "60 Minutes" segment that aired March 13, have created special global security teams to work with local law enforcement groups around the world to bust illegal drug counterfeiters. Those companies could save a lot of money if they could get the same kind of results from our own enforcement agencies — the "60 Minutes" segment included footage from an early morning raid of a Peruvian operation;

  • The definition of "valid prescription" should be extended to ensure that people can’t be diagnosed by imaginary doctors somewhere in cyberspace who are prescribing medications without ever having met the patient or seen a medical record;

  • Congress should grant Customs and Postal inspectors civil and criminal forfeiture authority under the Food and Drug Act. During the "60 Minutes" segment that appeared March 13, a package found in a U.S. postal facility to contain counterfeit drugs was simply shipped back to the sender; and

  • In general, the laws that prosecute manufacturers, distributors and marketers of counterfeit drugs should be more severe. Right now, drug counterfeiting is a low-risk/high-reward business. It might cost 40 cents to make a potentially lethal knock-off of a drug that you can sell for $20 a pill; and if you get caught, the worst thing that can happen is the post office will send your contraband back to you? They don’t even make you pay return-postage? No wonder so many drug traffickers are giving up coke and heroin for counterfeit Viagra, etc.

But mandating a federal track-and-trace system before the technology has been fully tested is a bad idea as it punishes legitimate pharmacies and wholesalers for having done the right thing all along. According to cost estimates conducted in recent years, implementing such a system could cost billions; potentially tens of thousands of dollars per pharmacy, to roll out a system that experts are not convinced is ready yet. Former Calif. governor Arnold Schwarzenegger was smart enough to see the need to push back electronic pedigree mandates in that state until the technology was ready, scalable and implementation no longer likely was to put hundreds of pharmacies in his state out of business.

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PHARMACY

Journal notes heart-related risks posed by Avandia

BY Alaric DeArment

LONDON — With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

Publishing results online in the British Medical Journal on Thursday, researchers at the University of East Anglia in the United Kingdom and Johns Hopkins University performed a review and analysis of 16 observational studies of a total of 810,000 patients using the drug, known generically as rosiglitazone, to assess their risk of heart attack, compared with those using Takeda’s Actos (pioglitazone). They found that patients using Avandia had a significantly higher risk of heart attacks, heart failure and death. Both drugs belong to the same class, known as thiazolidinediones, which work by targeting insulin resistance.

In response to studies indicating that use of Avandia could increase the risk of heart problems, the Food and Drug Administration placed restrictions on its use in September 2010. The agency also required GSK to create a risk evaluation and mitigation strategy, or REMS, for the drug, allowing its use when patients can’t control their blood-glucose levels with Actos.

But Actos might not be totally off the hook, either. On Friday, the European Medicines Agency announced it would investigate evidence linking the drug to bladder cancer in some patients. The FDA began its own review of Actos in September, based on five-year data from a 10-year study conducted by Takeda. Results showed that while there was no overall association between use of Actos and risk of bladder cancer, and the FDA had not concluded that the drug necessarily increased the risk, there was an increased risk among those taking Actos for the longest period of time and in the highest cumulative dose.

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Report: Menthol-flavored cigarettes could be latest banned tobacco product

BY Alaric DeArment

WASHINGTON — Menthol-flavored cigarettes are the latest target for tobacco opponents, according to published reports.

Reuters reported Friday that a committee of advisers to the Food and Drug Administration said in a report that banning mentholated cigarettes would benefit public health. Under legislation adopted in 2009, most flavored cigarettes already are banned.

The Food and Drug Administration will consider banning or limiting menthol when it receives the report Wednesday, though analysts have said a ban on menthol cigarettes is unlikely, Reuters reported.

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