From the American Academy of Ophthalmology

Legislation Now Awaits President’s Signature into Law

The U.S. Senate passed drug-compounding legislation today that provides only a partial solution to access issues for ophthalmologists and their patients. The bill, which previously passed in the U.S. House of Representatives and is off to President Obama to be signed into law, is a result of lawmakers’ efforts to tighten regulations on compounding pharmacies. The Academy is disappointed that the bill does not clarify physicians’ ability to access Avastin for office use. Ophthalmologists will likely not experience immediate changes in access to Avastin, however, as its repackaging will continue to be regulated under existing state and federal laws. Traditional compounding, which is typically reserved for patient-specific medications and very limited office use, will also continue to be regulated under current law.

The Academy did successfully secure several positive changes to the bill. Among them are:

• Exclusion of a national, patient-specific prescription requirement prior to dispensing compounded products;
• Access to essential medications compounded from bulk products (e.g., some preservative-free antibiotics) without having to identify the patient receiving the drug in advance; and
• Implementation of a review process with opportunity for public comment before the U.S. Food and Drug Administration attempts to place a drug on a “do not compound” list.

Because the bill maintains current law in key areas, the FDA will have significant discretion in deciding how repackaged products and drugs produced by traditional compounders for office use will be handled. The Academy will work to ensure that the agency recognizes the need for access to all necessary treatments in any regulations or guidance it implements. Senators have also told the Academy that they will take non-legislative steps to ensure ophthalmologists have access to repackaged drugs. Specifically, the Academy and ophthalmic subspecialty societies were able to negotiate commitments from Sens. Tom Harkin, D-Iowa, chairman of the Senate Committee on Health, Education, Labor, and Pensions, and Lamar Alexander, R-Tenn., ranking member on the committee, including:

• A letter to the FDA urging clarity on the role the newly created outsourcing facilities can play in giving providers access to safe sources of repackaged drugs;
• Statements on the Senate floor to clarify Congress’ intent to ensure access to repackaged medications;
• A hearing early in 2014 to conduct oversight of implementation of the legislation and ensure that patients’ access to quality compounded and repackaged drugs is not affected; and
• Meetings every six months with the FDA commissioner to receive an update on implementation of the legislation.

The Academy will continue to work with state and subspecialty societies to protect access to products from traditional compounding pharmacies.

For more information, contact the Academy’s Governmental Affairs Division at 202.737.6662.