Draft bill gives FDA authority over some pharmacies

WASHINGTON Fri Apr 26, 2013 12:32pm EDT

A sign for pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, is seen in Framingham, Massachusetts October 8, 2012. REUTERS/Jessica Rinaldi

A sign for pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, is seen in Framingham, Massachusetts October 8, 2012.

Credit: Reuters/Jessica Rinaldi

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WASHINGTON (Reuters) - The Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.

The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.

The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.

"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.

The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.

For example, these "compounding manufacturers" would not be required to submit their products to the FDA for approval before selling them. Nor would they be required to negotiate the labeling of their drugs with the FDA; they would only be required to indicate that the products are compounded and list certain other specified information.

These companies would no longer be licensed as pharmacies. They would be required to register with the FDA, and report to the agency any problems reported by patients or physicians. They would also be required to pay an annual fee to defray the cost of FDA inspections.

Compounding manufacturers would not be allowed to compound biologic products made from live organisms or other complex drugs. And they would be prohibited from compounding FDA-approved drugs unless they are in short supply.

Traditional compounding pharmacies would continue to be licensed and regulated by state boards of pharmacy.

A spokeswoman for the FDA, Erica Jefferson, said the agency was reviewing the draft "and looks forward to continuing to work closely with the committee to address existing limitations in the law."

It is unclear how many of the nation's roughly 2,800 compounding pharmacies would fall into the new category, but initial estimates put the number at fewer than 500. They would be defined not by their sales volume, but by whether they make products that are at high risk for contamination and sell them across state lines.

Ever since the meningitis outbreak, the FDA has been pilloried by Republicans in Congress, who say the agency should have been more aggressive in its oversight of NECC.

The FDA concedes as much but has argued that a complex legal landscape has hampered its ability to regulate the industry since compounding pharmacies have historically been regulated by the states and have not been required to register with the FDA.

The proposed legislation encourages greater communication among states and between states and the FDA. (Reporting by Toni Clarke in Washington; Editing by Vicki Allen)

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Comments (16)
pavoter1946 wrote:
Are the Republicans who pilloried the FDA over the oversight of compounding pharmacies the same ones who accepted lobbyist money to prevent the FDA from regulating them? The exemption was the result of intense lobbying, so who got the money?

Apr 26, 2013 10:23am EDT  --  Report as abuse
TheSonoran wrote:
“Ever since the meningitis outbreak, the FDA has been pilloried by Republicans in Congress who maintain the agency should have been more aggressive in its oversight of NECC.”

I thought the Republicans were the ones calling for “less” Government intervention into business? What gives?

Apr 26, 2013 11:12am EDT  --  Report as abuse
cbj wrote:
Really?
Where do you have your facts from?
If you look on Opensecrets you will see that in most cases the major industries contribute nearly 50/50 to both sides. (Of course the right leaning Finance industry is offset by the left leaning Unions).
Do you really think that the ‘Health Food Industry’ doesn’t try to lobby against regulating the Health Food Industry? Do you think that the ‘Complementary and Alternative Medicine’ Industry didn’t spend some money and twist some arms in order to be part of Obamacare?
I find it the height of absurity that part of the taxes I am mandated to pay go towards anything as unproven and psedo-scientific as Homeopathy is even part of the conversation.
Just look up ‘Integrative Healthcare Policy Consortium’

Apr 26, 2013 11:13am EDT  --  Report as abuse
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