By John Fritze, The Baltimore Sun
5:00 AM EDT, September 25, 2013
Lawmakers on Capitol Hill are closing in on a deal to grant the Food and Drug Administration more authority over the type of drugs that caused a deadly outbreak of meningitis last year, advocates close to the issue said Tuesday.
Though details of the proposal remain fluid, House and Senate negotiators have been talking for weeks and appear to be making progress toward stiffer regulations. The effort comes nearly a year after a Massachusetts compounding pharmacy recalled contaminated steroids that led to the outbreak.
Sixty-four people who received those steroid injections died, including three in Maryland. Hundreds more were injured.
"They've seen the problem, and they're moving forward to protect public health," said Tommy Thompson, a former secretary of the U.S. Department of Health and Human Services. Now a drug company executive, he leads an advocacy group supporting new standards.
The drugs at issue are made by compounding pharmacies, traditionally small operations which have tailored therapies for specific patients, such as by removing an ingredient from a drug if a patient is allergic to it. There's little desire to change the rules for those pharmacists.
But the practice has increasingly been used to make drugs that are supplied to physicians and hospitals for a much wider distribution, often across state lines.
Officials at the Silver Spring-based FDA have said that conflicting federal court decisions limit the agency's ability to regulate those larger compounding facilities and the drugs they produce.
Congress has been debating how to improve oversight for months.
A Senate committee approved a bipartisan bill in June that would require large compounding pharmacies to register with the FDA and pay an annual fee, which the agency would then use to increase inspections. The proposal also limits the types of drugs that could be compounded.
House lawmakers unveiled their own legislation earlier this month. The proposal clarifies the FDA's ability to regulate large pharmacies and creates a notification system to ensure the FDA responds to complaints made by state regulators.
The House bill, which also has bipartisan support, has received a warmer reception from groups that represent compounding pharmacists.
"The House took a substantially different approach," said David G. Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists.
"They started with the existing law [while] the Senate essentially started from scratch" and created new rules the group has argued could complicate oversight.
Since then, lawmakers in both chambers have been trying to find a middle ground between the two bills. While Miller said they have made progress, he cautioned that many stakeholders had not yet seen a draft of the latest proposal.
Several patient advocate groups have called on Congress to pass laws to prevent future outbreaks. Those groups also want lawmakers to include language that would make it easier to track drugs as they move through the supply chain.
"Meaningful policy is going to move a number of large scale [compounding] facilities under FDA oversight," said Gabrielle Cosel, manager of the drug safety project for the Pew Charitable Trusts. "We think that's the key."
Negotiations over the bill have captured significant interest from industry lobbyists — and not just from the pharmacists. Traditional pharmaceutical companies are concerned that the compound drugs are undercutting their own drugs without being subjected to the same rigorous FDA review.
About 750 people were injured in last year's outbreak nationwide, including more than two dozen in Maryland. Though the incident has largely faded from view, those affected continue to struggle with harrowing medical conditions.
Angel Farthing, a high school counselor from Abingdon, got a steroid shot in August 2012 for sciatic nerve pain. The tainted injection not only led to meningitis but also a related stroke, aneurysm and spinal abscesses. She's endured several hospital stays and surgeries since then.
The powerful drugs used to treat the infection caused the 42-year-old to lose much of her hair. The pain also forced the part-time fitness instructor to end the workout routines that likely had made her body strong enough to survive the meningitis.
"Even with all the medication, it does not stop the pain," she said, adding that she feels lucky because she's been well enough to return to work. "I'm really just left with sucking it up and hurting."
Farthing said it would be helpful if Congress could approve regulations to prevent a similar outbreak, though she's skeptical of how much the government can do.
"I feel like compounding is so big, I don't see how the government can take on the role of overseeing it," she said.
Maryland had aggressive laws in place prior to last year's outbreak, but the General Assembly approved a more comprehensive law this year. Those new regulations require pharmacies that make injectable drugs to receive additional permits.
And the new law requires out-of-state compounding pharmacies making drugs that aren't tailored for a specific patient to get a waiver from Maryland's pharmacy board before selling their product in the state.
An FDA spokeswoman did not respond to a request for comment. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, told lawmakers in July that the FDA was doing what it could but that it needed Congress to act.
"It is a matter of when, not if, another contamination incident will occur with compounded products," she said.
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