# Presentation: 725075

## The Prescription Drug User Fee Act

**November 14, 2005**

**Carole Redding Flamm, MD, MPH, Senior Medical Director, **
** ****	****Office of Clinical Affairs, Blue Cross Blue Shield Association**

## Agenda

- PDUFA’s impact on safety
- BCBSA recommendations to further strengthen and improve PDUFA

## Drug Safety Under PDUFA

- In 2001, BCBSA recommended expanding PDUFA user fee-funded activities include postmarketing surveillance
- PDUFA 2002 reauthorized expanded to include drug safety functions
- Monitor adverse event reports (AERs)
- Disclose Phase IV studies

## Safety Should be Integral to Delivering New Drugs

- Faster drug approvals mean potential side effects and interactions are often not known at the time of market entry
- Adverse drug events cause 770,000 injuries and deaths each year*
- Reliance on voluntary AERs is inadequate
*FDA Commissioner’s Report on PDUFA for FY 2004: http://www.fda.gov/ope/pdufa/report2004/commissioner.html*

## PDUFA’s Financial Impact on Safety

**Appropriations**

**User Fees**

**Total CDER Budget $439 million**

- CDER gets 47% of its budget from PDUFA Fees
- ODS gets 6% of CDER’s budget
- ODS gets 33% of its budget from PDUFA Fees
- Only 2.5% of PDUFA User Fees ($9 m) fund safety activities
*                                     *
*                                 ***HHS, Budget in Brief, FY 2006*

## Recommendation for Safety

- Keep PDUFA’s drug safety functions
- Devote additional PDUFA funds to the Office of Drug Safety
- Example: Raise proportion of user fees for ODS budget from 33% to 47% (same for CDER overall)

## Recommendation to Further Strengthen and Improve PDUFA

- Review PDUFA’s role in ensuring comparative information
- Include monitoring of DTC advertising compliance

## Comparative Information

- Consumers need information on relative costs, benefits, and risks of new drugs that replace existing therapies
- FDA should require manufacturers to provide this comparative information

**Asthma**
**More information about the relative value of various asthma treatments in terms of symptom-free days, decrease in work loss and any decrease in the use of inpatient services**

**Diabetes**
**Little is known about the effectiveness of new diabetes drugs compared to older therapies in terms of their ability to reduce incidences of microvascular complication and retinal problems **

## DTCA Oversight

- DTCA spending reached
- $2.7 billion in 2001*
- $3.2 billion in 2003**
- Today’s DTCA spending is $4.2 billion***
**GAO, “Prescription Drugs: FDA Oversight of DTCA Has Limitations” *
***Senator Kohl Press Release, “Kohl Chairs Hearing on DTC Prescription Drug Advertising,” September 29, 2005*
****PhRMA Live, MedAd News, October 2005: http://www.pharmalive.com/magazines/medad/view.cfm?articleID=2596*

## DTCA Oversight

- FDA’s Division of Drug Marketing, Advertising & Communications (DDMAC) is responsible for reviewing DTCA
- DDMAC total employees: 39*
- DDMAC employees that review DTCA: 5*
- DDMAC 2002 budget: $5.5 M**
- Consider extending PDUFA to DTCA review
*GAO Report,  “Prescription Drugs: FDA Oversight of DTCA Has Limitations”*
***“Direct-to-Consumer Advertising: You Get What You Pay For,” Health Affairs, April 28, 2004*

## Summary

- PDUFA has important role in improving safety
- Higher % of PDUFA fees should go to ODS/postmarketing activities
- PDUFA should ensure consumers get comparative information
- PDUFA should be expanded to DTCA monitoring