FACT SHEET
FDA Review of HIV Drugs

Secretary of Health and Human Services Tommy G. Thompson, Global AIDS Coordinator Randall Tobias, and Acting Food and Drug Administration (FDA) Commissioner Lester Crawford, announced an expedited pathway for FDA to review low-cost, safe and effective fixed dose combination (FDC—creating one pill out of two or three individual drugs), co-packaged (putting two or more pills into single packaging for distribution) and single ingredient HIV therapies for use under the President’s Emergency Plan for AIDS Relief.

What drugs can be reviewed through this pathway?

· Brand-Name Fixed-Dose Combination and Co-Packaged HIV Therapy Drugs. Today’s action encourages the development and provides expedited review for applications from brand-name companies (research and development based companies that hold the original patent for the individual drugs used to make up the FDC) for FDC and co-packaged HIV therapy drugs composed of drugs previously approved by FDA.

· Non-Brand-Name Fixed-Dose Combination and Co-Packaged HIV Therapy Drugs. 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.

· Non-Brand-Name Single Ingredient Drugs. Today’s action also provides expedited review from non-brand-name companies for generic forms of already approved single-ingredient HIV therapy drugs.

What scientific information is required from Applicants?

· Existing Clinical Data. FDA’s expedited review process for FDC’s or co-packaged drugs encourages companies to rely on existing data, including published literature, to support labeling for the combined use of already approved drugs rather than developing new clinical data. Normally, it takes a company 3-4 years to develop this information. FDA’s guidance provides a list of currently approved drugs for which the agency believes there are sufficient clinical data. In addition FDA will consider the following types of information in lieu of new clinical data:

o Peer-reviewed scientific literature reports of clinical studies. FDA’s guidance provides a list of drugs currently approved by FDA for which there are sufficient clinical data.
o Reference to a company’s own relevant data including data already submitted to FDA.
o Cross-reference to another company’s data (for which the applicant has obtained the reference rights).
o Reliance on FDA’s findings of safety and effectiveness for an approved drug product.

· Chemistry. For co-packaged brand-name products, only data showing that the drugs are stable in the new package will be needed. For new FDCs information showing that the combined drugs do not react with one another will be necessary. If a manufacturer has never submitted a description of the manufacturing process to FDA, additional information would be needed.

· Bioavailability Study. A bioavailability study is needed to show that the blood levels of the products when used in combination are at levels comparable to that achieved by the drugs used alone.

· Manufacturing Inspection. Plants manufacturing these products will have to pass an FDA quality inspection.

What are the time frames for review?
· Once FDA receives a completed application, it anticipates completing review of FDCs within 6 weeks . Review of applications for co-packaged products consisting of individually approved components with new combination labeling could be completed more quickly. FDA will provide technical assistance to those not familiar with the FDA process. FDA will also provide basic technical assistance to manufacturers who do not currently market a product, but wish to develop a product.

What will FDA review cost companies submitting applications?

· For new drugs, FDA typically charges a user fee of over $500,000. Congress has provided the Agency with authority to grant waivers of these fees when appropriate. To minimize the cost of submitting an application for review, FDA anticipates waiving fees for products proposed for use under the President’s Emergency Plan for AIDS Relief.

How much will the drugs cost?

· The process announced today does not directly relate to price. The Global AIDS Coordinator will create a competitive process to procure the lowest price in the future. Nonetheless, this pathway should significantly increase the number of companies and products that will compete for the Coordinator’s procurement. 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.