FDA Releases Analysis of HIV Drug Approval Program for Low-Income Countries


Fifteen years after the launch of a program to help bring HIV treatment to low-income countries, an FDA analysis shows the program is working, but there is room for improvement.

The US Food and Drug Administration’s (FDA) program to evaluate HIV drugs for use in low-resource countries is achieving its goals, but a new agency analysis finds there are also ways the program could be made more efficient.

Since 2004, the FDA has reviewed antiretroviral drugs as part of the President’s Emergency Plan for AIDS Relief (PEPFAR). The program, which is overseen by the US State Department, is designed to help prevent the spread of HIV in low-income countries and to treat people living with the condition in the more than 50 countries in which PEPFAR operates. The FDA’s role in the program is to help the State Department determine which antiretroviral therapies (ARTs) are safe and effective, and therefore worthy of use in the program.

In a new study, published in JAMA Network Open, officials from the FDA review the successes and challenges of the program, and offer recommendations to make it work even better.

The analysis found that the agency has received 260 applications through PEPFAR, representing 327 ARTs. Of those, 83% (216 applications representing 272 drugs) were eventually approved by the FDA. Of those approved drugs, the majority (184 applications encompassing 231 drugs) remain active and available for use.

Still, the authors write that the overall number of applications has been decreasing in recent years.

Corresponding author Harinder Singh Chahal, PharmD, MSc, of the FDA’s Office of Public Health Strategy and Analysis, told Contagion® that despite the relatively high number of approvals, it’s important that the pipeline of applications not dry up.

“The HIV treatment field is constantly evolving with newer, better treatment options,” Chahal said, pointing to new therapies, like dolutegravir, but also to new formulations, such as the strawberry-flavored pediatric HIV drug Quadrimune.

Furthermore, Chahal said a robust pipeline of applications is also important because it increases the likelihood of market competition.

“For instance, if PEPFAR is able to purchase the same HIV drug from 3 or more manufacturers, not only could that help reduce the per-patient pricing (which could help provide treatment to more patients), it could also ensure a stable supply of the drug if one of the manufacturing facilities goes offline for any reason,” he said.

The study pointed to a handful of possible reasons for the decrease in applications. Market saturation, a trend towards fixed-dose combinations instead of single-drug applications, new fees the FDA is required to charge for the applications, and State Department efforts to limit procurement to only clinically necessary drugs could all be playing a role, Chahal and colleagues write.

However, the review also found that the application process could run more smoothly if regulators and manufacturers communicated more proactively to avoid application deficiencies.

Thirty-seven percent of applications under PEPFAR received a complete response letter (CRL), which is the FDA’s method of communicating at least 1 deficiency in an application. The most common deficiencies were related to manufacturing processes, labeling, and facility inspections.

In most cases (55%), those deficiencies were resolved and the applications were eventually approved.

Chahal said many of those CRLs could be avoided if there were better communication, a problem he said that falls on the shoulders of both the FDA and manufacturers. He said the FDA issues documents and sometimes holds public meetings in an effort to make its expectations clear and transparent. But he said manufacturers can also take advantage of communication avenues made available by the FDA prior to drug application submissions.

“These meeting or written communications are intended to help applicants better understand FDA requirements so that an applicant can be reviewed effectively and efficiently,” he said.

“Applicants are encouraged to use these existing pathways to get relevant guidance from FDA.”

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