The United States plans to speed up the review of brand-name fixed-dose combination products and allow generic manufacturers outside the United States to apply for US Food and Drug Administration approval of their antiretroviral products. FDA approval would in turn allow the US government to buy generic antiretrovirals for use in developing countries – if they can beat branded products on price.
The announcement came on Sunday in Geneva, where US Health Secretary Tommy Thompson told reporters ahead of the World Health Assembly in a statement that drug patent issues that apply to developed nations should not impede purchase of antiretrovirals for developing countries.
The new FDA guidance outlines four scenarios for review of different FDC and co-packaged products. Some of the scenarios could permit approval in as little as two to six weeks after submission of an application.
According to a statement from the US Department of Health and Human Services, “FDA will also provide expedited review for applications from non brand-name companies for FDC and co- packaged HIV therapy drugs composed of drugs previously approved by FDA. Non-brand-name companies can submit applications on their own or develop partnerships with brand-name companies.”
While a marketing application cannot be approved to permit sale in the United States until applicable patents or exclusivity protections expire, the FDA can grant `tentative approval`, showing that a product has met all FDA scientific standards for safety, efficacy, and quality. Such tentatively approved products would then be available for procurement under the President’s Emergency Plan for AIDS Relief.
Whilst manufacturers of branded products will find the new process straightforward and speedy, generic manufacturers will still have some hurdles to overcome to win `tentative approval`.
If generic manufacturers do not win permission from branded manufacturers to cite safety and efficacy data owned by the innovator companies they will have to rely on studies from the peer-reviewed scientific literature in order to support their applications. If these studies do not answer all the FDA’s questions, they may have to carry out their own research.
Producing copies of fixed-dose combinations already approved by the FDA is likely to be much more straightforward, with no need for generic manufacturers to refer to safety and efficacy data to justify the combination of drugs. Companies would need only to submit bioequivalence data and information on the manufacturing process.
A manufacturing inspection will be carried out. This should not prove a problem for large manufacturers like Cipla, which are used to manufacturing under contract to major US and European pharmaceutical companies.
At the same time, the US Global AIDS Coordinator will also carry out a tendering process to procure antiretrovirals. In a challenge to generic manufacturers, the US Global AIDS Coordinator said: “It has been claimed that some HIV/AIDS therapies may cost as low as $140 per year. All companies with products are encouraged to participate in this process and compete in the procurement.”