Counterfeit Drug Bill Makes Slow Progress in Congress

The proliferation of fake drugs finally has the attention of Congress. Last week, the House of Representatives passed a bill requiring prescription medicine to be tracked electronically through the distribution system.

After years of counterfeit drug reports involving, among others, the cancer drug Avastin and the cholesterol drug Lipitor, it’s a meaningful gesture, but, according to a story on MedPageToday, some industry observers say the legislation doesn’t have enough bite to tame the rabid dog.

The Safeguarding America’s Pharmaceuticals Act would create a national “track and trace” system in which manufacturers, distributors and pharmacies would monitor drug products through the whole supply chain. It’s supposed to identify not only counterfeit drugs, but stolen and adulterated meds as well.

As we’ve seen all too often-remember the contaminated steroids from the Massachusetts compounding pharmacy last year? And last month’s report of another compounding pharmacy contamination in Tennessee? -drugs that aren’t made and shipped properly can be lethal. And the global scope of this commerce makes it difficult to regulate.

Critics of the proposed law say not requiring scrutiny at a drug’s unit level undermines its effectiveness. The unit level is a smaller sampling of a manufacturer’s total output. There might be thousands of units within a whole lot. And the unit level, say critics, is where counterfeiting occurs. It’s easier to steal or mess with small portions of a large lot of which only a bit is tested to escape tracking.

It’s the same principle of food inspection-a fish inspector might examine a few pounds of someone’s catch while most of the bounty remains unseen.

The House bill calls for only an “enhanced” system … and not until 2027. There’s no requirement for final rules or implementation. And, as explained by MedPage, once rules are finalized, it’s an additional two years before they could go into effect.

It could be as late as 2030 before drugs are required to be tracked at the unit level under this bill.

Several medical and patient advocacy organizations, including the American Society of Clinical Oncology and the American Public Health Association, are opposed to the legislation. And the FDA, according to MedPage, has supported unit-level tracing.

Some observers assume that the House bill is only the first phase in a more complete process. The Senate’s version of the bill requires unit-level tracking after 10 years.

Both bills are better than anything the states have going, although some, at least, are paying attention.

Ohio Rep. Bob Latta, a sponsor of the House bill, blogged last week: “By replacing the current patchwork of multiple state laws with a uniform national standard we improve safety, eliminate duplicative regulations and create certainty for members of the pharmaceutical supply chain.”

But why does it have to take so long?

Counterfeit and compromised drugs can be killers-see our blog “The Health Hazards of Counterfeit Drugs.” Would such lethal actors be given such a long leash in other industries?

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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