GROUP CALLS FOR, SENATOR CONSIDERS BROADER REVIEW OF COMPOUNDING
Sen. Chuck Grassley (R-Iowa), a frequent critic of the FDA's drug safety policies, is considering expanding his investigation into compounding following lobbying by activist groups.
Grassley recently sought information from the FDA and the Centers for Medicare & Medicaid Services (CMS) about their handling of inhalational drug compounding. Compounding is a practice in which pharmacists manufacture prescription drugs from bulk ingredients.
But the senator is now considering whether to expand his review. "Based on the concerns raised about other compounded medications, he may look at compounding more generally," Jill Kozeny, Grassley's spokeswoman, said.
However, the senator will not make a decision about whether more regulation or a legislative remedy is necessary until he gets a response from the FDA and the CMS. While Grassley has yet to hear from the CMS, the agency has promised that its response will be provided by the end of this week, Kozeny added.
In the meantime, the FDA would only say that it "will not tolerate drug manufacturing disguised as pharmacy compounding," an agency spokeswoman said. "Firms that mass-compound drugs that are basically copies of FDA-approved drugs are at risk for agency enforcement."
Among the many critics of compounding is the Allergy & Asthma Network Mothers of Asthmatics (AANMA), which has been lobbying numerous lawmakers for changes in the law to increase federal oversight of compounding. The group recently held a briefing for Sen. Edward Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.) to push for legislative changes.
During that July 21 briefing, the group presented case studies on compounding problems, argued for greater cooperation between the FDA and the CMS in overseeing compounding and presented a survey on compounding that the group provided to numerous healthcare professionals about the use of compounded nebulizer medications. The results of that survey are due this week, Nancy Sander, the president of AANMA, said. The group is also continuing to follow up with congressional staff.