FDA to Have More Authority Over Pharmacies?
Apr 26, 2013 03:23 PM EDT
A new proposal from lawmakers would give the U.S. Food and Drug Administration greater control over compounding by pharmacies, according to Reuters.
The FDA would have authority over pharmacies that compound sterile drugs and send them around the country under the new proposal from a bipartisan group.
This new proposal comes in the wake of a meningitis outbreak that claimed the lives of 53 people. In addition the outbreak, which was connected to a faulty steroid, sickened over 700 people. New England Compounding Center, based in Framingham, Massachusetts, was responsible for distributing the tainted steroids.
The proposal would differentiate pharmacies that compound drugs for specific patients from compounding pharmacies that make and ship drugs around the country for physicians.
Since the outbreak, Congressional Republicans have said the FDA was not hard enough in regulating NECC.
While the FDA admits accusations are true, regulating the industry is not easy. The agency says there is a complex legal landscape, resistance from compounding pharmacies and constantly changing functions of the industry. All of these make regulation less than feasible.
The proposal would create a new category for drug companies entitled, “compounding manufacturers.” Those within the categories would be controlled by the FDA but would not be subject to all of the regulatory rules that apply to the major pharmaceutical companies.
For instance, the companies would not be asked to have their products examined by the FDA for approval. Also they would not have to negotiate with the FDA on what should be allowed to appear in the package insert.
So far, there are no indications for which specific companies would fall under the regulations. In addition they would not be selected by how much pharmaceuticals they sell but by whether or not their products are at a greater risk for combination. Another factor that will go into the categorization is whether or not the company ships their drugs across state lines.
The categorized companies would be required to register with the FDA and also bring reports to the agency concerning complaints. They would cease to be licensed as pharmacies and be required to pay a fee every year to take care of the cost of FDA inspections.
Compounding pharmacies not included in the category would still be overseen by a board of pharmacy from each state.