A crucial first step is to ramp up the availability of treatment services and medical supplies. That will be a challenge, but it also offers pharmaceutical manufacturers a great opportunity to demonstrate their ability to provide affordable, effective treatments. Generic drug makers are already playing an important role in these efforts—a role they are poised to expand if innovator firms shy away. Meanwhile, the industry has to formulate effective combination products, meet worldwide regulatory standards, and obtain ingredients—an assignment that will stress pharma on all sides. Bristol-Myers Squibb, for example, reported in March that it might not meet demand for Zerit (stavudine) and Sustiva (efavirenz).
The delisting raised questions about the reliability of WHO's prequalification system, a skepticism shared by US health officials. Even though WHO maintains that the incident demonstrates its ability to maintain high standards, PEPFAR requires drugs purchased with US dollars to be approved by FDA, ostensibly to fend off charges that America foists lower-quality treatments on poor nations.
Critics of the US position believe PEPFAR's real goal is to protect pharma patents. A commitment to purchasing FDA-approved products translates into a commitment to buying more high-cost brand-name drugs—ultimately limiting the number of patients treated. FDA's solution is to grant "tentative approval" to generic drugs that meet regulatory standards (and thus are eligible for purchase by PEPFAR programs) but cannot be marketed in the United States for patent reasons. A May 2004 FDA guidance spells out how manufacturers can develop and gain expedited review of FDCs and co-packaged ARVs.
Although many observers still regard FDA's approach as costly and unnecessary, the prospect of qualifying for purchase by PEPFAR is attracting applicants, and the accelerated-review policy has helped bring new AIDS therapies to market quickly.
In January, Aspen Pharmacare of South Africa received the first tentative approval for a co-packaged drug regimen that includes two tablets each of generic versions of Glaxo's Combivir (lamivudine/zidovudine) and Boehringer's Viramune (nevirapine). A generic version of Combivir from India's Aurobindo Pharma gained tentative approval in July. FDA has also okayed many individual generic AIDS treatments, including lamivudine, zidovudine, nevirapine, efavirenz, and stavudine—and a dozen applications are in the review pipeline.
FDA has been able to approve PEPFAR applications in four to eight weeks. FDA deputy commissioner Murray Lumpkin says that is because the Office of Generic Drugs (OGD) is providing a lot of hand-holding to generics companies, especially those unfamiliar with agency policies. Speedy approvals require quality applications and early inspection of BE data and manufacturing facilities."