FDA should require that generic isotretinoin applicants implement their own pregnancy prevention programs instead of incorporating the generics into Roche's Accutane risk management program, Roche argued in a Feb. 5 citizen petition.

"Rather than requiring that each ANDA applicant adopt a program design that conforms to the SMART design, FDA appears to be moving in precisely the opposite direction, namely, changing the SMART program from one that is product-specific to one that relates to all isotretinoin products," the petition states.

"This would turn the Hatch/Waxman provisions on their head," Roche declared. "FDA must require generics to copy the innovator, not change the innovator to conform to the generics."

Roche's citizen petition, prepared by the Washington D.C. office of Covington & Burling, asks FDA to delay approving isotretinoin ANDAs until standards are in place to ensure that pregnancy risk management programs for generics can be coordinated with the SMART program, can be linked to the specific drug product dispensed, and have their own drug-specific data collection system in place.

Pediatric exclusivity for Accutane expired Feb. 7, and generics are awaiting ANDA approval. Mylan said it expects approval imminently, following the resolution of generic labeling issues with FDA.

FDA, Roche and generic companies met on Feb. 6 to discuss the future of the isotretinoin risk management program and addressed some of the concerns brought up in Roche's petition. Although Roche noted it was pleased with the discussion and found it fruitful, a final decision on management of the program was not reached, the company said.

Roche's System to Manage Accutane Related Teratogenicity program requires prescriber registration, "qualification stickers" for prescriptions, and monthly visits to the doctor for pregnancy tests. FDA approved the program Oct. 30 (¹ Also see "Roche Accutane Prescriber Registry Added To Pregnancy Prevention Program" - Pink Sheet, 5 November, 2001., p. 3). The program expands on the company's pregnancy prevention efforts for the nodular acne drug.

In the petition, Roche reminded FDA that the agency's continued acceptance of the program hinges on detailed data collection on compliance. "It would be both unfair and unlawful for FDA to take action against Accutane based on those other systems and products, which are beyond Roche's control," the company maintained. "Roche cannot take any responsibility for the risk management systems or drug products of any other manufacturers."

Roche expressed concern about the logistical "complexities that can arise in the context of multiple products."

For example, "a woman may be provided the materials of one manufacturer in her physician's office, and the prescriber may use that manufacturer's qualification sticker, only to have another manufacturer's product dispensed at the pharmacy."

In addition, "she may enroll in the epidemiologic survey conducted for the first manufacturer while in the doctor's office, or the other manufacturer's survey at the pharmacy, or both. A third manufacturer's drug - or the first manufacturer's - might be dispensed for the second month's prescription."

As a result, "if there is failure to comply with each element of the program it is unclear how the system will ensure that this is accurately allocated to the responsible manufacturer," Roche said. "FDA's failure to address these issues will lead to unreliable measurements of numerators and denominators."

Roche appears to favor a system whereby prescriptions, and stickers, are specific to each manufacturer, with epidemiological results tracked accordingly. However, the logistical burden this could likely place on doctors and pharmacists may be a reason FDA is leaning toward a non-product-specific program.

The American Academy of Dermatology is one organization that lobbied against the SMART program's physician registration provision (² Also see "10 Roche Accutane Patient Registry Anticipated By Mid 2001 - FDA" - Pink Sheet, 11 December, 2000., p. 10).

AAD is holding a two-day consensus conference on the isotretinoin risk management program in conjunction with its annual meeting in New Orleans Feb. 22-27, with issues surrounding generic market entry likely to be on the agenda.

Accutane Generics Need Separate Risk Management Programs, Roche Says

More from Archive

More from Pink Sheet