Pharmaceutical Compounding Quality and Accountability Act

Senate Health Committee Passes Alexander and Colleagues’ Bill to Fix Responsibility for Safety of Sterile Compounded Drugs
Alexander says, under legislation, “when you walk into a facility that makes drugs, you will know who is regulating that facility—there will be no confusion about who is in charge of keeping that product safe” Compounding bill will include legislation to create tracking system for nation’s 4 billion prescriptions, “making sure they are what they’re supposed to be—that they’re not counterfeit, they’re not stolen, that they actually work”

Wednesday, May 22, 2013Liz Wolgemuth 202-228-4729

Washington, D.C., May 22 – The Senate Health, Education, Labor and Pensions Committee today passed legislation introduced by Ranking Member Lamar Alexander (R-Tenn.) and his colleagues to fix responsibility for the safety of sterile compounded drugs and, Alexander said, “avoid another outbreak like the meningitis nightmare that killed 15 Tennesseans and made more than 150 people in our state sick.” The next step is consideration by the full Senate.

Alexander said: “This bill is an important step forward for fixing responsibility for safety of sterile compounded drugs. The bottom line is that, under this legislation, when you walk into a facility that makes drugs, you will now know who is regulating that facility. There will be no confusion about who is in charge of keeping that product safe.”

He added: “I do not intend to sit through another hearing where FDA can point its finger at someone else instead of taking responsibility for its failure to regulate and enforce large-scale compounding, or claim it didn’t have clear enough authority.”

The Pharmaceutical Compounding Quality and Accountability Act establishes three categories for the businesses that make compounded drugs. The first category, traditional pharmacies, will continue to be regulated by states. The second category, drug manufacturers, will continue to be regulated by the FDA. The legislation creates a new category for large-scale drug compounders and calls these businesses “compounding manufacturers.” These businesses make sterile compounded drugs in advance of a prescription and sell them across state lines.

Alexander explained: “The New England Compounding Center (NECC) would have fallen into this category. The legislation puts the Food and Drug Administration solely in charge and on the flagpole for overseeing these ‘compounding manufacturers.’”

He added: “Under our bill, compounding manufacturers will be regulated by the FDA, and, for example, they are subject to regular FDA inspections. NECC was not inspected between 2006 and 2011 by the state or the FDA. Under our bill, compounding pharmacies must report the products made at that facility to the FDA. NECC was making copies of commercially available drugs, which is illegal. Under our bill, they must report to the FDA when things go wrong with a product. Currently, large scale compounders are not required to report to the FDA if they know about a problem with a product. And finally, they must label their products, so patients and doctors know it is compounded, rather than FDA-approved.”

Also at today’s committee markup, the committee passed the Drug Supply Chain Security Act, a bill to create a new system for tracking drugs from the manufacturer to the pharmacy. This bill will be joined with the compounding legislation in one bill.

Alexander said today of the drug tracing legislation: “I’d like to emphasize what a big step this is. We have about 4 billion prescriptions per year in the United States, and this legislation would create a tracking system for those 4 billion prescriptions made by over 88 manufacturers on over 3,600 manufacturing lines, which are distributed to patients in a variety of ways, including by 60,000 pharmacies or drug stores.”

He continued: “This will over several years create a system where we can track each of those prescriptions and make sure that they are what they are supposed to be—that they’re not counterfeit, that they’re not stolen, and that they actually work. It was a big undertaking to write the bill, and it will be an even more important undertaking to assure the safety and the accuracy of these 4 billion prescriptions.”

In the last year alone there have been three cases of counterfeit Avastin, a cancer drug, being distributed in the U.S. to physicians and patients, when the counterfeit did not contain any of the active ingredient.

The United States has seen an increase in drug theft, but there is currently no way of knowing if and when those drugs are resold back into the U.S. supply chain.

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