SENATOR SENDS LETTER TO FDA, CMS ON DRUG COMPOUNDING

Sen. Chuck Grassley (R-Iowa), a frequent critic of the FDA's drug safety policies, is turning his sights toward drug compounding in an effort to address allegations of fraud and safety concerns.

The senator "is working to jumpstart efforts to curb inappropriate and/or illegal compounding of inhalational drugs," Jill Kozeny, Grassley's spokeswoman, said.

There are numerous problems with drug compounding, a practice in which pharmacists manufacture prescription drugs from bulk ingredients, that jeopardize public health and defraud the Medicare and Medicaid programs, Grassley said in a letter to the heads of the FDA and Centers for Medicare & Medicaid Services (CMS). Grassley's July 13 letter recounts a four-month investigation his staff undertook into allegations of inappropriate compounding of inhalational drugs.

Grassley's investigation found several instances where pharmacists substituted compounded medications for manufactured drugs without notifying patients or their doctors and misled patients by telling them the compounded drugs were generic versions of the brand drugs. Some patients reported that they became ill or their conditions did not improve after receiving the drugs, the letter added.

"If these allegations are true, then the committee is greatly concerned about the health and safety of the patients using these drugs as well as the financial impact that unsafe and/or ineffective compounded medications may have on the Medicare program," the letter said.

Grassley wants both agencies to provide answers about what they are doing to address concerns with this practice, including what the federal role should be in regulating compounding and whether the FDA needs additional authority to respond to inappropriate or illegal compounding. The senator is also asking the CMS whether it will modify how it reimburses for inhalational drugs. Grassley expects an answer by Aug. 3.

Meanwhile, compounding advocates say that state laws are sufficient to regulate the practice and that any problems are isolated. "Illegal substitution is already improper under state law and is regulated by state boards of pharmacy," L.D. King, the executive director of the International Academy of Compounding Pharmacists, said in a statement. "We are confident that any instances of illegal substitution are isolated," he added.

The FDA declined to comment and CMS did not reply to a request for comment. The letter is available at: www.senate.gov/~finance/press/Gpress/2005/prg071406b.pdf (http://www.senate.gov/%7Efinance/press/Gpress/2005/prg071406b.pdf). (http://www.fdanews.com/did/5_139/)