# Presentation: 605979

##   President’s Emergency Plan for AIDS Relief  and FDA

**Murray M. Lumpkin, M.D.**
**Acting Deputy Commissioner**
**US Food and Drug Administration**
**US Department of Health and Human Services**
**PACHA**
**07 February 2005**

## Quality ART

- Host of essential activities and services
- Procuring quality antiretroviral drugs (ARV) and other medicinal therapies
- when the world market is composed of counterfeits, poor quality, unknown quality, and good quality drugs

## Challenges - ARV	drugs

- How to assure that ARV and other medicines purchased under PEPFAR are QUALITY products?
- Those receiving get greatest benefit from therapy
- Risks of developing resistance are limited as much as possible
- How to assure that the programs gets the best value for dollar in its drug purchasing efforts in order to help treat the largest number of patients possible?
- How do we address the issue of asking governments to give their people product that we would not give our own people?

## FDA Expedited Marketing Application Review Process

- In May 2004, in direct support of PEPFAR, Department of Health and Human Services (DHHS) then Secretary Tommy Thompson announced that FDA would implement a new, “expedited review process” for certain drugs to ensure that the US could provide safe and effective  QUALITY drugs under the PEPFAR program

## Components of this Process

- No change in FDA standards – efficacy, safety and manufacturing quality (including inspections – GCPs, GLPs, and GMPs
- Open to all manufacturers
- Use of “tentative approvals” if patents block marketing in the USA
- No repetition of clinical efficacy trials for combinations when using 21 single entity products approved in US
- Faster review and decision by FDA
- Intensive interactions with potential manufacturers prior to submission of marketing application

## FDA Guidance

- FDA published guidance for the Pharmaceutical Industry encouraging manufacturers to submit marketing applications for fixed dose combination (FDC) and co-packaged versions of previously approved single entity anti-retroviral therapies

## FDA Guidance

- Posted on www. fda. gov on May 17, 2004
- Outlines scenarios for review of different FDC and co-packaged products
- Generic versions of already authorized products
- New products
- Describes components of a high-quality marketing application

## Pre-Application Activities

- Due to the unprecedented nature of the PEPFAR initiative, reviewers will work intensively with potential manufactures and help work through the complex nature of scientific and regulatory questions encountered; *especially, if the prospective manufacturer has little or no experience with the FDA*

## Application Activities

- FDA conducts its traditional drug product review activities for both new products and generic forms of existing drug products to ensure product safety, effectiveness, and manufacturing quality
- FDA has committed to expedite the review of these marketing applications – generally 6 – 8 weeks after a complete marketing applications is submitted

## Application Activities

- Generally, a priority review designation provides for the review of a new drug  application in 6 months or less
- The statutory review time for a generic drug marketing application is 180 days
- Generic and new drug (new combinations of already approved single entity products) applications received under PEPFAR would be reviewed within even shorter time frames (approximately 8 weeks)

## Inspections

- Because many manufacturers will have little or no experience with FDA, FDA will not have existing information about most clinical laboratories, clinical trial sites, and manufacturing sites
- Therefore, FDA will conduct pre-approval inspections of laboratories, cGCP and cGMP inspections to ensure the integrity of the data in the marketing applications and the drug product quality during manufacturing

## Tentative Approval

- For companies making products where another firm owns the US patent rights, FDA could issue a “tentative approval” when it finds the product meets the FDA’s normal safety, efficacy, and manufacturing quality standards
- Except for the patent blocking, the product could be marketed in the US
- Will assure all products purchased under the PEPFAR program are products that we would give to our own people

## Outreach Activities

- FDA has developed comprehensive outreach programs for potential manufacturers and national drug regulatory authorities that seek to participate in PEPFAR. This includes:
- Train-the-trainer sessions
- Training for general marketing application and approval process information
- Assessment of current good manufacturing practices and current good clinical practices
- Post-market adverse event reporting and analysis

## Update

- We do have applications in house under review
- Some companies have made this fact public
- Until approval of a product, FDA is required by law to keep this information confidential
- Additional companies have approached us

## Update

- Approvals
- December – Barr (US)
- Didanosine delayed-release capsules
- Tentative Approvals
- January – Aspen (South Africa)
- Lamivudine 150 mg / zidovudine 300 mg FDC        co-packaged with nevirapine 200 mg
- 2 tablets – each taken BID (first 14 days the nevirapine is QD)

## Update	

- Large symposium here in US for Drug Regulatory Authorities from all 15 PEPFAR countries planned for April

## Thank You

- Questions?
- Comments?