From the American Academy of Ophthalmology

The U.S. House of Representatives passed drug-compounding legislation Saturday that would provide little relief from access issues for ophthalmologists and their patients. Despite the advocacy efforts of the Academy and other physician associations, lawmakers passed a bill that excludes provisions negotiated in earlier House and Senate proposals to protect ophthalmologists’ access to office use of compounded drugs and products that have been repackaged. Under the House-passed bill:

• The U.S. Food and Drug Administration would decide how to regulate repackaged drugs, like Avastin; the legislation does not address the issue. The bill would instead leave it to the FDA to determine if and how physicians could access repackaged products for office use.
• Ophthalmologists would be able to access other compounded drugs, such as antimicrobials, for office use from new outsourcing facilities – compounders that voluntarily come under FDA oversight and meet federal safety standards for drug manufacturing.
• Traditional compounding – typically reserved for patient-specific medications and limited office use – would be preserved and operate under current law.

While the FDA would have significant discretion in deciding how office use is handled and repackaged products are made available to physicians, the Academy does not expect immediate significant changes in ophthalmologists’ ability to access compounded drugs if enacted into law. However, the Academy anticipates that changes would come when the FDA begins implementation.

The Academy was successful in securing several positive changes to the bill, including:

• Exclusion of a national, patient-specific prescription requirement prior to dispensing compounded products.
• Access to essential medications compounded from bulk products without having to identify the patient receiving the drug in advance.
• Implementation of a review process before the FDA attempts to place a drug on a “do not compound” list.

The Senate has not scheduled a vote on the legislation, but lawmakers are seeking consideration early this week. The Academy and ophthalmic subspecialty societies will continue to work with the FDA and the states to protect access to quality compounded products.

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