November 30, 2012
Chairman Tom Harkin Ranking Member Mike Enzi
731 Hart Senate Office Building 379A Senate Russell Office Building
Washington, DC 20510 Washington, DC 20510
Comments from Members of the Patient, Consumer, and Public Health Coalition
Re: FDA’s Recent HELP Committee testimony on pharmacy compounding
Dear Chairman Harkin and Ranking Member Enzi,
As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views regarding FDA Commissioner Margaret Hamburg’s November 15, 2012 testimony at the HELP Committee hearing, “Pharmacy Compounding: Implications of 2012 Meningitis Outbreak.” HELP staff asked us to focus our comments on FDA’s recommendations for a proposed risk-based framework, and on FDA’s request for additional statutory authorities to regulate pharmacy compounding companies.
Commissioner Hamburg’s risk-based framework addresses many of the same issues that HELP staff asked stakeholders to address earlier this month. Commissioner Hamburg’s comments also mirror many of the proposals in Congressman Edward Markey’s Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. We generally support the VALID Act because it will give the FDA the clear regulatory authority it needs to prevent tragedies such as the contaminated steroid injections that have resulted in hundreds of cases of fungal meningitis and more than 30 deaths.
The compounding industry and others argue that FDA already has the authority it needs to regulate non-traditional compounding companies. However, the uncertainty regarding the status of section 503A due to different interpretations of the law by the Fifth and Ninth Circuit Courts has led to non-uniform enforcement in the U.S. Congress needs to take legislative action so that FDA has clear, unambiguous authority to apply the law uniformly nationwide. There should not be one set of laws for Texas, Louisiana, and Mississippi (the Fifth Circuit), and another for the rest of the country. Congress should absolutely clarify the legal status of section 503A, which should be revised to delete the unconstitutional advertising provision.
Additionally, FDA’s authority to regulate pharmacy compounding companies has been challenged by compounders. Commissioner Hamburg stated in her testimony that the New England Compounding Center (NECC) “has repeatedly disputed FDA’s jurisdiction over its facility.” NECC claimed that the state of Massachusetts had jurisdiction, rather than the FDA.
At the recent House and Senate hearings on compounding, there was sharp criticism of the FDA for not using the authority it already has to shut down what was characterized as large-scale drug manufacturing by NECC under the guise of pharmacy compounding. Although we agree that the FDA should have done more, the blame is similar to blaming an underfunded police department for a city’s high crime rate. FDA has been underfunded for years, which means they do not have enough “cops on the beat” to adequately regulate the enormously diverse and complex medical products industry. User fee agreements, which were meant to address budget shortfalls, may have exacerbated safety problems because user fees mandate that FDA meet industry performance goals that focus almost entirely on speed of approval for new medical products—not on safeguards, such as inspections, post-market surveillance, or enforcement.
At numerous hearings on the reauthorization of PDUFA and MDFUA, industry railed against stronger FDA oversight, and many Members of Congress echoed those pressures. The tragic deaths from a preventable outbreak of fungal meningitis is an important reminder that essential regulations will save lives. Rather than responding with constructive strategies to improve patient safety, some of the same people who demanded less FDA oversight are blaming the Agency for not aggressively regulating compounding pharmacies.
Commissioner Hamburg began her risk-based framework remarks by stating her support for FDA’s long-standing policy that compounding should be performed by a licensed pharmacist or licensed physician, and that there must be a prescription or an order for individual patients who need a compounded drug. We agree.
We also agree with the Commissioner’s following recommendations:
- What are currently called compounding pharmacies include traditional and non-traditional, and non-traditional should be subject to Federal standards. Commissioner Hamburg was specific in identifying products that would be in the non-traditional category (sterile compounded drugs, large volume of drugs being produced, whether the drug is shipped interstate among other items). While Commissioner Hamburg said that non-traditional compounding products should be subject to Federal standards and urged Congress to strengthen Federal standards, we believe that many of these non-traditional compounders are actually manufacturers and should be regulated as such.
- Non-traditional compounders that are not manufacturers should be subject to greater oversight, such as current Good Manufacturing Practices (cGMP) that comply with FDA standards.
- Certain drugs should not be compounded. There should be no copies of FDA-approved drugs (except in the rare situation of shortages or to address urgent public health issues).
- States should have a role in regulating traditional compounders and there is a legitimate role for traditional compounders (for example making doses appropriate for children or preservative-free doses).
Additional FDA Authority Requested
Commissioner Hamburg stated that the FDA’s ability to take action against compounding “has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA’s authority.” The Commissioner recommends that FDA have clear, full authority to collect and test samples of compounded drugs and be able to examine the records of compounders (such as prescriptions received and the volume of products shipped). We agree. Compounding companies should not be able to stonewall the FDA.
The Commissioner stated that non-traditional compounders should register with the FDA. We agree. How can the FDA provide oversight, if the Agency is unaware that a company is engaged in compounding?
The Commissioner also urges Congress to explore requiring non-traditional compounders to report adverse events, and to fund inspections and oversight of non-traditional compounders with registration or other fees. We strongly support adverse events reporting and registration fees to support inspections and oversight.
Stronger regulations are clearly needed to prevent tragedies such as those caused by NECC’s contaminated steroid injections. Current laws and regulations regarding compounding pharmacies are not as clear as they should be, and this has allowed medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk.
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For more information, contact Paul Brown at (202) 223-4000 or email@example.com