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Health Care Regulation
Fri November 9, 2012
Regulating Pharmacies To Protect Public Health
Congresswoman Rosa DeLauro met Thursday in North Haven with public health officials and pharmacists. She heard their views on how the federal government could better regulate compounding pharmacies.
The fungal meningitis outbreak that infected more than 400 people and caused 31 deaths across the country has been traced to a pharmacy in Massachusetts.
At a roundtable discussion, Congresswoman Rosa DeLauro said the U.S Food and Drug Administration should have more authority to monitor the compounding industry. "I don’t view this as an isolated incident. But I think it is a warning for us with regard to the regulatory process."
Compounding pharmacies create customized drugs for patients who have special healthcare needs.
Eric Tichy, a pharmacist at Yale-New Haven Hospital said the industry has grown in part, because its hard to get certain FDA-approved drugs from large manufacturers. "Some of these manufacturers have been shut down for whatever reason and why are they not coming back on line? Is it the regulatory process? Because it’s a lot easier to regulate three or four big manufacturers than it is to regulate 3000 compounding pharmacies."
And John Gadea, director of the Drug Control Division of Connecticut’s Department of Consumer Protection, said packaging regulations also add to the drug shortage. "If you have a vial that’s 10 cc’s, the current use of that product is only 2 cc’s. But it’s a single dose vial, so now you wind up adding to the drug shortage by every time you open a vial, wasting 8 cc’s."
DeLauro says she’s looking for a balance between over-regulating and keeping people safe. "We do have a responsibility. The FDA is a regulatory agency. And it shouldn’t be overburdening, but it should have the responsibility for regulating when it comes to drugs, devices, tobacco and food."
DeLauro plans to introduce legislation aimed at regulating the compounding industry later this month.