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NCL testimony at the FDA on Prescription Drug User Fee Act

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Public hearing statement on re-authorization of the Prescription Drug User Fee Act by Sally Greenberg, Executive Director, National Consumers League before the U.S. Food and Drug Administration

October 24, 2011

Docket No. FDA-2010-N-0128

Good morning. On behalf of the National Consumers League (NCL), I would like to thank you for the invitation to share a consumer-oriented perspective on proposed recommendations for the re-authorization of the prescription drug user fee act (PDUFA 5).

Established in 1899, NCL is the nation’s oldest nonprofit consumer education and advocacy organization. NCL provides government, businesses, and other organizations with the consumer's perspective on numerous policy issues including child labor, privacy, food safety, and medication safety and information. From the first Pure Food and Drugs Act passed in 1906 to the more recent FDA Modernization Act, NCL has been working – often alongside the Agency - to ensure that the public is adequately represented and protected, and that our medications are safe and effective.

It is in this context that NCL expresses concern that many of the recommendations for this re-authorization of PDUFA are focused on reducing perceived barriers to new drug approvals rather than on protecting and promoting the health of patients and consumers by ensuring access to safe and effective medications. The other consumer groups represented on this panel, all members of the Patient, Consumer and Public Health Coalition, also share this overriding concern.

NCL believes that we should have a drug approval process that provides timely access to safe and effective drugs while reducing exposure to harmful drugs that pose undue risk. We recognize that PDUFA must balance the needs of consumers who are concerned about serious side effects with the concerns of patients who may be facing a life-threatening illness where time is of the essence. Thus, while it is important to have an efficient and timely approval process, there is still, in our view, too little emphasis on performance goals aimed at improving the safety and efficacy of drugs.

We continue to be concerned that the public has too little opportunity to fully engage in the PDUFA process. While we appreciate the FDA’s efforts to keep stakeholders informed about the negotiations and to solicit our input on the proposals under discussion, consumer and patient groups were not present during the negotiations, and, as a result, several patient safety and consumer protection initiatives that were put forward were never discussed in the formal dialogue with industry. We believe that the PDUFA proposal should not be move forward without these additional provisions. I will be addressing several of those issues today.

1. Direct to Consumer Advertising of Prescription Drugs

NCL has long been interested in ensuring that consumers receive accurate and useful information about their healthcare, including information about the safe and effective use of prescription drugs. With over four billion dollars spent a year on DTC ads [1] and over 91% of Americans reporting that they have seen or heard advertisements for prescription drugs[2], DTC ads have become an integral part of communicating information on prescription drugs. Consumers are continually exposed to these ads, and it is imperative that the FDA have the staff and resources to ensure the ads are accurate and not misleading BEFORE they reach the public.

As we have mentioned in previous testimony before the FDA, we recommend that the agency be granted the authority to require that all DTC ads undergo review before public dissemination. This would enable agency staff to work with industry to revise materials where needed so that misleading information does not reach consumers. Without the authority to make review a condition of broadcasting, product sponsors have no incentive to submit their ads for agency review. NCL urges the FDA to make the review of ads for newly approved drugs a top priority. FDA should consider placing a moratorium on all DTC advertising for new drugs, especially those deemed to have inadequate safety information. Based on available safety data, the agency could be given latitude in determining the appropriate length of the moratorium on a product-by-product basis. NCL would support adding a third “provisional” status for some new drugs, which would allow limited exposure of a product to appropriate patients. This would mitigate the likelihood of inappropriate use and over-exposure while additional post-approval safety data collection is ongoing.

In order to conduct such oversight of DTC advertising, we suggest that user fees be allocated to support hiring of additional staff to review ads and respond to industry feedback in a timely fashion. There is currently a dangerous imbalance between the volume of DTC advertising and the resources available for monitoring and reviewing the advertisements. This imbalance becomes even greater when considering the growing number of Internet and social media advertising for prescription drugs. As consumers increasingly turn to the Internet for health information, it will be more important than ever for FDA to have the resources to ensure that consumers receive balanced information about the drugs advertised to them

2. Adverse Event Reporting and Medwatch

Because reports of adverse events from consumers and healthcare professionals may be the first indication of a drug’s safety problem, it important that consumers are able to easily report any adverse events with medical products, and that FDA is able to capture and act upon that information. We are encouraged by the improvements that FDA is making to the Medwatch form for consumers. If FDA wants to encourage voluntary consumer reporting of adverse events, the Agency must ensure that reporting mechanisms are consumer-friendly. While we support FDA’s revisions of the Medwatch form, those revisions will fail to address the fact that the complaints entered into Medwatch are rarely used because of how the information is captured by the FDA. We understand that the information electronically collected on Medwatch is not able to be easily transferred to a usable electronic format so that any trends can be easily identified. The Medwatch system is not an active surveillance system; it is, in fact a passive program. We suggest that these issues be resolved so that Medwatch can effectively serve as an early warning system in a larger post-market safety surveillance system

3. Off-Label Prescribing

While off label use of medications can sometimes be beneficial, the majority of medications so prescribed have no valid scientific evidence in support of such prescribing.[3] A recent review by the Agency for Healthcare Research and Quality found that while antipsychotic drugs are used for many off label indications, for the majority of the medications there was little evidence of benefits, and in some cases there are serious adverse effects.[4] From a consumer perspective, many people are likely unaware they are even being prescribed off label drugs. Consumers should be informed about the following if they are prescribed drugs off label:

  • Availability of alternatives
  • Body of evidence supporting product use
  • Approval status/use in other countries
  • Implications for insurance coverage

Finally, we urge that under PDUFA V funds be directed to examining the safety of off- label prescribing, and the implications of lack of consumer awareness and understanding of the practice.

In conclusion, we believe the proposed recommendations must do more to ensure the safety of patient and consumers, and the scientific integrity of the drug review process. Thank you for giving the National Consumers League the opportunity to present our views on this important hearing related to the reauthorization of the Prescription Drug User Fee Act.


[1] Lian, Bryan, et al, “Direct to Consumer Advertising with Interactive Internet Media”, JAMA vol. 305, no. 8, February 23, 2011.

[2] Kaiser Public Opinion Spotlight, “Public and Physician Views on Direct-to-Consumers Prescription Drug Advertising” at http://www.kff.org/spotlight/rxdrugsconsumer/upload/Rx_Drugs_DTC_Ads.pdf

[3] Radley, et al. (2006) “Off-label Prescribing Among Office-Based Physicians,” Archives of Internal Medicine, 166: 1021-1026.

[4] AHRQ Effective Health Care Program, “Off-Label Use of Atypical Antipsychotics: An Update,” Comparative Effectiveness Review Number 43 (2011).