Research Policies Pose New Challenge for US Administration - White House and Congress likely to struggle over funding for bio/pharmaceutical regulation. - BioPharm International


Research Policies Pose New Challenge for US Administration
White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

BioPharm International
Volume 25, Issue 12, pp. 10-11


Meanwhile, mounting deaths from contaminated steroid injectables made by a Massachusetts compounding pharmacy are focusing attention on the need for broader FDA legal authority in this and other areas. The need to reauthorize animal-drug user fees in 2013 is expected to provide a vehicle for legislation that would better secure the prescription drug supply chain and also address drug compounding oversight. (For more information on this subject, view "Compounding and FDA Regulation" on

The ongoing fungal meningitis outbreak had sickened more than 425 individuals and caused over 30 deaths, as of early November. Rep. Edward Markey (D-MA) has proposed legislation to enhance FDA oversight of compounding pharmacies, and lead House and Senate committees held hearings right after election day to address the response by FDA and state regulators and to analyze actions by the offending compounder, the New England Compounding Center (NECC). Markey's bill clarifies FDA's right to inspect and regulate large compounders that qualify as drug manufacturers. Small compounding pharmacies would continue to operate under state licensing, and FDA could issue waivers to operators responding to drug shortages and public health crises. Compounded drugs have to be labeled that they have not been tested for FDA safety and efficacy standards, and FDA has to publish a list of unsafe or ineffective drugs not suitable for compounding.

FDA regulation of compounders has been a thorny issue for decades, as previous efforts by the agency to impose stricter rules on compounders have been struck down by the courts. But the recent crisis has reopened the debate over the adequacy of state versus federal regulation of pharmacies and when compounding qualifies as drug manufacturing.

Efforts by FDA and Massachu-setts regulators to shut down NECC and its sister company, Ameridose, highlight the links between drug shortages and compounding. FDA Commissioner Margaret Hamburg noted that the agency is working hard to minimize shortages in important Ameridose products used in surgery and to prevent congestive heart failure. Yet, former FDA official Scott Gottlieb also commented that too-tight FDA regulations have led to shortages of low-cost injectable drugs, prompting hospitals and patients to seek alternatives from compounders. Too-low reimbursement for generic injectables also may limit pharmaceutical industry interest in producing these therapies, leading to shortages and greater reliance on compounders.

KV Pharma weighed in that the NECC case illustrates FDA's error in permitting compounders to continue to produce hydroxyprogesterone to prevent premature births after approving KV's Makena. State health agencies and insurers have been opting for the less costly compounded version, but now may shift to the KV product to avoid exposure to possibly unsafe compounded medicines.

There will be further debate over how much added legal authority FDA needs to deal with compounders. Some agency critics complained that FDA did not make full use of its existing legal authority to regulate NECC following initial unsatisfactory inspections. Republicans generally oppose giving the agency stronger legal powers, and compounding pharmacies claim they are sufficiently regulated by state licensing boards. Pharmacists object to the Markey bill for imposing too-broad FDA regulation of compounding that could block patient access to needed medicines and further overtax FDA. It's a cost-versus-safety issue, and a challenge to find a compromise that passes muster.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,
. Read Jill's blogs at

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