Sunday, November 24, 2013

Senate Passes Drug Compounding Bill; Senators Make Floor Statements to Clarify Intent on Office Use and Repackaging

This week, the Senate passed by voice vote H.R. 3204, the Drug Quality and Security Act. The bill, which seeks to improve safety of compounded drugs, is a compromise between the House Energy and Commerce and Senate Health, Education, Labor, and Pensions (HELP) Committees, and creates a new category of pharmacy—outsourcing facilities—that would voluntarily submit to stricter FDA oversight. The bill is now awaiting signature by the President.
During the legislation development, ASCRS and the ophthalmic community have worked to ensure that physicians and patients would continue to have access to compounded drugs. H.R. 3204 incorporated some of the provisions advocated for by the ophthalmic community such as eliminating a national requirement for patient-specific prescriptions for all compounded drugs, a national requirement that physicians ordering compounded drugs made from bulk substances provide a patient name in advance, and adding a provision for the opportunity to review FDA recommendations before certain drugs are placed on a “do not compound” list. However, the new law does not include repackaging in the compounding definition and leaves it to the FDA to determine how repackaged drugs, such as Avastin, would be regulated. In addition, it does not adequately address physicians’ continued access to compounded drugs for office use.
ASCRS and the ophthalmic community have raised concerns that despite the sponsors’ intent not to limit access, that without explicit language concerning repackaging and office, it is unclear how the FDA would enforce the law.
The bill’s Senate co-sponsors, HELP Committee Chairman Sen. Tom Harkin (D-IA) and Ranking Member Sen. Lamar Alexander (R-TN) committed to ensuring that the intent of the bill was not to override state laws regulating office use or to limit repackaging and will send a letter to the FDA clarifying the intent of the law. During consideration on the floor, both senators made statements clarifying the intent. Further, they have committed to holding a HELP committee hearing early next year to examine implementation of the legislation.
In addition, other Senators noted the ophthalmic community’s concerns and made remarks on the Senate floor during consideration to ensure physicians and patients have access to compounded drugs for office use and repackaged drugs. Sen. John Boozman (R-AR) stated, “The omission of office-use from section 503(a) of the Food, Drug and Cosmetic Act should not signal to the FDA that it has the authority to encroach upon state authority to regulate office-use. This is not the intent of the law, and I will closely monitor FDA implementation as this process moves forward.” Further, Sen. Tom Coburn, MD (R-OK) said in his statement, “This legislation does not change the ability of ophthalmologists to administer drugs in their office to individual patients for the purposes of reducing macular degeneration. Under this legislation, physicians retain the ability to use compounding drugs in their office for their patients. This is a practice-of-medicine issue, so the art and science of medicine should not be impeded by the FDA.”
ASCRS thanks members who contacted their legislators to help preserve the ability to provide the care your patients need. ASCRS will monitor this issue as the Drug Quality and Security Act is implemented.

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