BETHESDA, MD 10 May 2013—Seven months after the emergence of fungal meningitis and other serious infections associated with tainted drugs made by a compounding pharmacy, Congress appears ready to move legislation to bolster FDA's authority over the industry.
The Senate Health, Education, Labor, and Pensions Committee in late April released a discussion draft of proposed legislation that would classify certain businesses as "compounding manufacturers" and subject their production of sterile products to heightened regulatory scrutiny.
Joseph Hill, ASHP's director of federal legislative affairs, said the Society worked closely with the Senate committee's staff to shape the proposed legislation. Before the document was released, Hill said that both Congress and FDA appeared to grasp the areas of concern for health-system pharmacy.
"They know where we're coming from," Hill said.
The proposed legislation distinguishes between compounding manufacturers and traditional compounding pharmacies.
Compounding manufacturers are defined as businesses that prepare sterile compounded products without first receiving a patient-specific prescription and sell the products to out-of-state entities. A business "that repackages a drug using sterile preservative-free single-dose vials or by pooling sterile drugs" would also be classified as a compounding manufacturer.
Compounding manufacturers would be required to follow good manufacturing practices, investigate and report adverse events, and report specific information about compounded products to regulators every six months.
The draft legislation's definition of a "traditional compounder" includes state-licensed pharmacies in which a pharmacist compounds a product pursuant to a patient-specific prescription or prepares a limited amount of a compounded product for an identified patient on the basis of the patient's past need for the product.
The draft legislation would prohibit a business from registering as both a pharmacy and a compounding manufacturer. No pharmacy would be able to compound products designated as "complex" dosage forms, biologics, or, in most cases, currently marketed drugs.
Health-system pharmacies, even those that ship sterile compounded products out of state to other facilities within the health system, can be classified as traditional compounders under the proposed legislation.
ASHP's initial public comments on the document voiced support for that provision, in particular, and stated that the Society is pleased with the proposed legislation overall.
ASHP submitted written comments on the proposed legislation in response to the committee's request for public input.
Hill said the Senate committee expected to finish its work on the bill by Memorial Day.
The draft legislation appears to incorporate requests made by FDA Commissioner Margaret A. Hamburg during recent appearances before Congress.
During testimony on April 16 before the House Committee on Energy and Commerce subcommittee on oversight and investigations, Hamburg acknowledged that FDA was slow to take action against the New England Compounding Center (NECC) and its sister company, Ameridose, in response to reports of unsafe practices at the Massachusetts facilities.
"I regret that we didn't do more, and I regret that I was not more directly engaged. But I am now," she said.
When Hamburg spoke, the official toll from the NECC-related outbreak of fungal meningitis and related infections stood at 733 cases, including 53 deaths.
In a replay of her appearance before the subcommittee last November, Hamburg and FDA garnered scathing criticism from several members of Congress [see January 1, 2013, AJHP News].
After the initial hearing, FDA released to the subcommittee more than 27,000 pages of documents, some describing multiple reports to FDA of serious deficiencies at NECC and Ameridose.
"Many of us are troubled by what we've learned" from those documents, Michigan Representative Fred Upton told Hamburg during her April 16 appearance before the subcommittee. He said the newly released documents show that despite receiving "complaint after complaint" dating back to 2002, FDA action against the companies "simply didn't happen."
But the agency is taking action now. Hamburg told the subcommittee members that FDA had recently identified and inspected 29 compounding pharmacies that make and sell sterile injectable products. These inspections have resulted in numerous product recalls.
Problems cited in FDA's inspection reports include insufficient microbiological testing, inadequate air filtration systems, poor product handling techniques, and failure to investigate problems found with finished products.
Hamburg told the subcommittee members that FDA is concerned about the "serious lapses in sterility procedures" uncovered during the inspections.
According to FDA, some pharmacies continue to challenge the agency's right to perform full inspections. Two of the 29 pharmacies that were targeted for inspection this year required FDA to obtain an administrative warrant before releasing records to the agency.
Four pharmacies "initially refused to permit FDA investigators access to records or to allow observation of their sterile processing activities" but later relented, in some cases after seeking legal counsel, according to FDA.
Hamburg said these incidents underscore the need for Congress to provide FDA with explicit authority to oversee pharmacies that engage in high-risk compounding.
The proposed legislation would bring compounding manufacturers under FDA's full inspectional oversight, require them to release all records requested by the agency, and allow FDA unfettered access to any facility under inspection.
The International Academy of Compounding Pharmacists (IACP), a trade group that represents compounding pharmacies, released a statement April 25 that was critical of some portions of the proposed legislation.
IACP stated that the term "compounding manufacturer" and "several of the definitions of that new category" are confusing and "further blur the jurisdictional authority of regulators."
The trade group also indicated "grave concern" that hospital pharmacies would be exempt from "many" of the regulatory changes proposed in the draft legislation.
FDA estimates that there are approximately 28,000 U.S. pharmacies that compound products, including about 3000 that compound sterile products.