The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.
Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.
“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).
In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.
“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.
“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”
Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.
Insulin and human growth hormone “have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”
Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.
“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”
He noted that he talks every day with patients who are concerned about difficulty in paying for biologicals and other medications.
“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naïve legislators,” he said.