Compounding Hearings Are First Step In Creating Active Legislative Ingredients

Congress will explore causes and potential policy solutions to the meningitis outbreak at the New England Compounding Center in back-to-back hearings, but any legislation increasing FDA regulatory authority faces a long road.

Pharmaceutical compounding is supposed to start with a prescription, or at least the reasonable expectation of one.

Following the recent meningitis outbreak at the New England Compounding Center, drug industry stakeholders should have the reasonable expectation that legislatively prescribed solutions could be coming, but when the legislative ingredients will be actively mixed is less certain.

Policy approaches will be discussed during two congressional hearings on the compounding issue. The House Energy and Commerce Oversight and Investigations Subcommittee will convene Nov. 14, followed by the Senate Health, Education, Labor and Pensions Committee the next day.

FDA also appears interested in exploring the possibility of more authority. Center for Drug Evaluation and Research Director Janet Woodcock said in a Nov. 6 memo to staff for that some agency officials “are assisting congressional leaders on, potentially, new authorities.”

Rep. Ed Markey, D-Mass., already has filed a bill that would increase FDA regulation of compounders, including requiring those whose volume is more like mass manufacturing to register with FDA and submit to inspections.

The bill would prevent compounding of commercially-available drugs, unless there are special circumstances like a shortage. It also would require compounders to receive a waiver to produce drugs before receiving a prescription.

Members should ask about FDA’s interest in the bill during the House hearing, but pharmacy groups already have identified problems with it, including provisions they say could penalize legitimate compounding.

Markey’s bill and the hearings signal the start of an extended effort to deal with the issue, and several other pieces of legislation could emerge if the issue continues to command congressional attention.

A similar process unfolded when Sens. Amy Klobuchar, D-Minn., and Robert Casey, D-Pa., introduced legislation to mitigate drug shortages in 2011.

Reps. Diana DeGette, D-Colo., and Tom Rooney, R-Fla., later introduced legislation building on the idea in the House (Also see "Drug Shortage Legislation Gains Momentum With Bipartisan House Bill" - Pink Sheet, 27 Jun, 2011.). The final compromise proposal was included in the FDA user fee reauthorization bill, which was enacted in July (Also see "GOP Drug Shortage Strategy Pushes FDA Reform, Reimbursement Over Notification" - Pink Sheet, 13 Feb, 2012.).

A Marriage Of Compounding, Track-And-Trace?

The compounding bill could be paired with drug tracking legislation, which was considered during the debate on the user fee legislation but did not make the final bill.

Analysts at Prevision Policy suggested the two issues are similar enough that Congress could take them together. They also said that while unlikely, it is possible the package could be added to deficit reduction legislation, although scoring may be difficult because the regulations likely would increase drug costs.

Given the highly politicized nature of the deficit and the short time the lame duck Congress has to reach an agreement, it seems unrealistic that congressional leaders would risk endangering a deal over compounding, however.

FDA and stakeholders remain committed to finding a track-and-trace solution, so passage after the new Congress comes to town seems more likely.

The HELP Committee recently released a new track-and-trace draft and asked for feedback from stakeholders (Also see "Track-And-Trace Proposal Starts With Serialization, Explores Unit-Level Tracking" - Pink Sheet, 25 Oct, 2012.).

A Question Of Compounding And Manufacturing

Part of the problem appears to be drawing a legal line between traditional compounding and manufacturing.

The National Community Pharmacists Association said in a recent statement that some parts of the Markey bill could solve problems like those at the Framingham, Mass.-based NECC.

But it also said many of the proposed regulations, such as requiring waivers to compound some drugs, could create “overly broad requirements” for pharmacists and restrict patient access.

NCPA said the focus should be on preventing large-scale drug manufacturing under the guise of compounding laws, while still allowing traditional compounding to continue.

“[The bill] gives FDA new broad sweeping powers to regulate small business when the agency can hardly keep up with its existing workload,” NCPA said in its talking points on the issue. “This goes way beyond addressing the NECC situation.”

The American Society of Health-System Pharmacists also said regulatory authorities will need more help and must work together if more evidence of compounding problems emerge.

“State boards of pharmacy will need additional resources to provide strict oversight of compounding pharmacies and provide more transparency,” ASHP CEO Paul Abramowitz said in a recent column for the group’s newsletter.

The pressure on FDA to increase oversight of compounders comes as the agency is in the process of implementing new user fee agreements, including one that requires increased inspections of generic drug manufacturing facilities (Also see "GDUFA Guidance Offers Peek At Generic Drug User Fee Levels" - Pink Sheet, 27 Aug, 2012.).

The agency also is undergoing a philosophy change regarding its overseas facility oversight. Officials have admitted that FDA cannot regulate all facilities around the world and want to eventually rely on the information gathered by other trusted regulators (Also see "FDA’s Globalization Strategy Needs To Be More Aggressive, Sen. Brown Suggests" - Pink Sheet, 19 Apr, 2012.).

House, Senate Hearings Could Take Divergent Paths

FDA Commissioner Margaret Hamburg is expected to receive a hefty batch of criticism from members of Congress during both hearings over her agency’s role in preventing the outbreak.

The House hearing is intended to explore whether the meningitis outbreak could have been prevented. It will address such issues as whether the FDA and Massachusetts Board of Pharmacy enforcement actions were appropriate and why the agencies did not act sooner, according to the subcommittee majority’s background memo.

Hamburg and Lauren Smith, interim commissioner of the Massachusetts Department of Public Health, will appear at the hearing, according to the Energy and Commerce Committee website. Barry Cadden, NECC president, co-owner and director of pharmacy, was subpoenaed and is listed among the witnesses.

The HELP Committee may include broader issues. The hearing title is “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.”

Its witness list also is more expansive. Hamburg, Smith and Cadden are scheduled to appear, along with Beth Bell, director of the National Center for Emerging and Zoonotic Diseases at the Centers for Disease Control & Prevention.

The committee also will hear from a policy-oriented panel, signaling it also could consider regulatory changes. David Miller, executive VP and CEO of the International Academy of Compounding Pharmacy, and Kasey Thompson, VP in the ASHP Office of Policy, Planning and Communications, are scheduled to appear together on a panel.

A Senate companion for the Markey bill has not been offered yet, but Sen. Richard Blumenthal, D-Conn., has indicated an interest in considering legislative options.

Several other members also requested briefings and information from FDA and the Department of Health and Human Services about the outbreak and existing regulatory authority (Also see "FDA’s Compounding Oversight: What Price Safety?" - Pink Sheet, 15 Oct, 2012.).