Saturday, September 14, 2013

House Bill Would Expand FDA Role in Pharmacy Oversight

Three House lawmakers Thursday introduced their version of bipartisan legislation to clarify the Food and Drug Administration’s oversight of compounding pharmacies.

The bill (HR 3089), from Virginia Republican Morgan Griffith and Democrats Gene Green of Texas and Diana DeGette of Colorado, is similar to legislation (S 959) the Senate Health, Education, Labor and Pensions Committee approved by voice vote in May.

Both would create a new category for pharmacies that compound sterile medications and ship them across state lines, which the FDA would oversee. Under both bills, state boards of pharmacy would continue to have primary oversight over traditional compounding pharmacies.

The legislation brings Congress one step closer to passing legislation in response to last year’s fatal fungal meningitis outbreak caused by a contaminated injectable steroid.

“These discussions have been productive and are ongoing, and by dropping this bill we are keeping the pressure on House leadership and maintaining the momentum we have built,” said Green in a statement.

In the House bill, the FDA would oversee “outsourcing facilities” — pharmacies that ship sterile compounded drugs across state lines and that have those drugs account for more than 5 percent of the products they produce.

Those facilities would have to register annually with the FDA, report and list the drugs they compound, report adverse events to the FDA, and label their products. They also would be subject to inspections on a risk-based schedule and pay an annual establishment fee and fees for reinspections, starting at $15,000.

Griffith’s office said the bill would replace a section of law that has been the subject of conflicting court decisions, which FDA officials say has resulted in an ambiguous regulatory situation.

The legislation also would require implementation of a notification system between the FDA and state boards of pharmacy to improve communication.

And it would allow the FDA to create lists of drug ingredients that cannot be compounded due to safety or efficacy concerns, and of drugs are demonstrably difficult to compound. It would ban the compounding of products that are essentially copies of marketed and approved drugs.

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