Monday, September 23, 2013

Federal officials make slow progress on regulating drug compounders

A year into a fungal meningitis outbreak that has killed or sickened more than 700 Americans, federal lawmakers and health authorities still struggle to find a way to keep it from happening again. FILE - In this Oct. 16, 2012 file photo, a Food and Drug Administration Agent stands at the doorway of New England Compounding Center in Framingham, Mass., as investigators work inside. House lawmakers introduced legislation Thursday, Sept. 13, 2013, that would bring more federal oversight to large specialty pharmacies like the New England Compounding Center that triggered a deadly meningitis outbreak in 2012.     

Congressional staffers from the U.S. House and Senate have negotiated over the last two weeks, consulting with health advocates and industry lobbyists, on legislative language to best protect Americans from contaminated compounded drugs. Too often those drugs are produced by large compounding pharmacies that ship huge quantities of medications between states without prescriptions and without federal oversight.

One such pharmacy in Massachusetts compounded the contaminated steroid injections that have killed 64 people in the last year.

Voters strongly support a clearer and more invasive role for federal drug safety regulators in overseeing the practice of pharmacy compounding, a new poll has found.

In the survey of 800 registered voters, 77 percent of respondents said they would support giving the U.S. Food and Drug Administration more authority to regulate compounded drugs and compounding pharmacies.

The poll was commissioned by the Working Group on Pharmaceutical Safety, a coalition of drug manufacturers and health advocates that supports stronger federal oversight over pharmacies that compound large amounts of drugs outside of FDA regulations.

Traditional compounding is the pharmacy practice of mixing medications from scratch to meet the individual needs of a particular patient. In recent years, however, public health advocates have become alarmed as some pharmacies have grown to resemble drug manufacturers. But conventional drugmakers must comply with strict federal rules ensuring their products are safe and effective, standards that do not apply to compounders.

The risks and potential dangers of pharmacy compounding first were exposed in a Kansas City Star series more than a decade ago.

The meningitis outbreak, which first appeared in a case reported to Tennessee health authorities on Sept. 18, 2012, rekindled a long-standing debate over how much, or how little, authority the FDA should have over the practice of pharmacy compounding.

Though Congress quickly held hearings on the current outbreak, progress toward clarifying what role the FDA should have in compounding has been measured. Bills in the Senate and the House have been stalled as successive waves of domestic and international crises have washed over the nation’s capital.

But the voting public — at least that reflected in the poll — now appears ready to see strong action, said Tommy Thompson, a drug company executive and co-leader of the safety group.

At least 95 percent of those surveyed said it either was “very” or “somewhat” important to them to have any prescription drug they’re taking reviewed and approved by the FDA. About the same percentage said it was as important to be informed if the doctor was prescribing a non-FDA approved drug, and just as important to be told of FDA-approved alternatives.

“These results show overwhelming support among Americans that the federal government should provide oversight to ensure the safety of the medications that doctors prescribe,” said Thompson, who served as Health and Human Services secretary during the George W. Bush administration.
Poll numbers aside, nobody is proposing that the FDA wrest all regulation of compounding from state boards of pharmacy, which traditionally have regulated such practices.

In the spring, Kansas Republican Sen. Pat Roberts teamed with Sen. Lamar Alexander of his own party and Democratic Sens. Tom Harkin and Al Franken to propose the most sweeping overhaul of FDA authority over compounding in more than a decade.

The Senate bill, which passed out of committee without opposition, would carve out a new category of compounders for FDA oversight, calling them “compounding manufacturers.” Any pharmacy that shipped sterile compounded drugs across state lines without prescriptions would face heightened FDA safety scrutiny.

A bipartisan House bill announced recently proposed improving communication between the FDA and state pharmacy boards. The legislation also would create a new class of pharmacy subject to FDA authority. Similar to “compounding manufacturers,” so-called “outsourcing facilities” would be subject to annual registration, reporting and listing of drugs they compound.

Reaction to the Senate bill was mixed, and sponsors created an exemption that would allow pharmacists to sell limited amounts of sterile and non-sterile drugs without prescriptions to doctors’ offices so they could be dispensed as needed.

The House bill, called the Compounding Clarity Act, contained a less-restrictive “office use” provision, which did not limit non-sterile products, such as topical creams. That proposal immediately drew the endorsement of the National Community Pharmacists Association.
“The House legislation appropriately addresses the issues that led to the (meningitis) tragedy and prevents another tragedy from occurring while also not interfering with the physician-patient-pharmacist relationship and maintaining critical patient access to compounded medications,” Douglas Hoey, the association’s chief executive officer, wrote in a letter to House sponsors.

The association objected to the Senate legislation, saying it proposed expanding the FDA’s authority far beyond the drug safety issues raised by the meningitis outbreak.

Large drug manufacturers, which customarily have not spoken out on compounding issues, also joined the discussion this month.

Two trade associations, the Generic Pharmaceutical Association and the Biotechnology Industry Organization, weighed in against the House bill, complaining that it provided too many ways for compounders to copy their products “outside of any FDA approval pathway to ensure the safety and efficacy of these prescription drugs.”

House and Senate aides now are working to resolve differences between the bills — particularly on the “office use” question — and settle on a bipartisan proposal that would be acceptable to a majority in both chambers.

The staff negotiators, and their bosses, could simplify their work by considering what the public expects of its medications, said pharmacist and longtime compounding safety advocate Sarah Sellers.
“Any legislative proposal should meet the common sense expectations of voters for oversight and disclosure,” said Sellers, who also sits on the safety group. “The message is clear: Close the loopholes that have endangered patient safety for too long.”    

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