National Consumers League


NCL Health Issues

Examining the Prescription Drug User Fee Act

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Read NCL's testimony to the FDANCL's Sally Greenberg testified before the FDA recently about the re-authorization of the Prescription Drug User Fee Act, calling on the federal agency to seize this opportunity to critically examine the impact of the program, and make meaningful changes to enhance the safety of drugs in this country.

Public hearing statement on the re-authorization of the Prescription Drug User Fee Act
By Sally Greenberg, National Consumers League
Before the Food and Drug Administration

April 12, 2010

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 of the Prescription Drug User Fee Act (PDUFA).

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.

It is in this context that NCL calls on the FDA to seize the upcoming PDUFA re-authorization as an opportunity to critically examine the impact of the program, and make meaningful changes to enhance the safety of drugs in this country.

I would now like to turn to the specific questions posed for this public meeting.  The first question - “What is your assessment of the overall performance of the PDUFA program thus far?”

NCL believes that the work of the Food and Drug Administration is of such critical importance that it warrants funding from the general Treasury commensurate with its many responsibilities.  Given budgetary constraints, however, the user fee system is the only viable option to ensure adequate funding for the foreseeable future.  Ideally, the user fee funds would be appropriated to the general FDA budget, with no conditions for its use.  While Congress has, to date, allowed the regulated industries to dictate how FDA allocates its resources, NCL believes there is too much at stake to allow this funding model to persist.  

There is an ongoing perception that the FDA has become too close to the companies over which it has regulatory authority.  This view is only exacerbated by the fact that the public has relatively little opportunity for input into the rules governing product review and oversight.  PDUFA provides a clear example of this.  When PDUFA was first created, the FDA consulted with Congress and the life sciences industry, leaving health care consumers – the Agency’s most important constituency – out of the loop.  Over time the system has been improved somewhat, with PDUFA IV including consumers in the re-negotiation process.  However, as Bill Vaughn from Consumers Union has noted,  in order for the consumer community to fully engage in the process, we need to know what industry is proposing during the negotiations, not when they are  completed.  For this reason, we believe that minutes from the negotiations with industry should be made public as they occur so that consumers have a chance for bona fide input.  Until consumer interests are directly represented in the final negotiations process, the FDA will not truly serve its customers. 

NCL fully supports the ideal that enhanced drug approval processes benefit everyone.  However, faster approval does not always mean better.  While getting safe and effective drugs to market as quickly as possible is a laudable goal, quicker approval has drawbacks. Rapid approvals can mean and has meant – that consumers are exposed to unnecessary and often deadly risks.  While we are pleased that  PDUFA IV allocated over $29 million of the $392.8 annual user fee revenue (about 7%) to patient safety initiatives, we recommend a larger percentage of the user fee revenue be directed to patient safety.  Increasing the amount devoted to patient safety activities from the current 7% to 25% of total user fee revenue would reinforce the important idea that the FDA believes patient safety requires an equal place alongside a speedy approval process.

I will now turn to the second question: “What aspects of PDUFA should be retained, changed or discontinued to further strengthen and improve the program?” 

We commend the FDA for the drug safety activities that have been implemented under PDUFA IV.  However, much more needs to be done.   NCL has a number of additional suggestions, but we will focus on DTCA review, reporting adverse events, and off-label use.  We also support many of the suggestions already made by members of this panel - including those offered by Consumers Union pertaining to generic drugs and clinical trials.

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 on DTCA in 2008 [i] and over 91% of Americans reporting that they have seen or heard advertisements for prescription drugs [ii], DTCA has become an integral part of communicating information on prescription drugs.  Consumers are continually exposed to these ads, and it is FDA’s responsibility to make sure they are accurate and not misleading BEFORE they reach the public.  Since the voluntary DTCA user fee program introduced under PDUFA IV failed, NCL suggests the following actions:

  • FDA should be granted the authority to require that all DTC ads undergo agency review BEFORE public dissemination.  Without the authority to make review a condition of broadcasting, product sponsors have no incentive to submit their ads for agency review.
  •  User fees should be assessed for the review of the full spectrum of media reaching  consumers, NOT just television ads (which is the current situation under PDUFA IV). Under PUDUFA V,  print, radio, Internet AND television should be included. To review only television ads is highly problematic given the extent to which campaigns tend to be coordinated and integrated across multiple media in order to maximize impact. User fees should be a mandatory part of the submission of any DTC ad – regardless of medium - to the agency. The revenue derived from the fees could be used to support a number of currently under funded Agency activities, including hiring of additional staff to review - and respond to industry feedback in a timely fashion. 
  • Inclusion of a “Drug Facts Box” in DTC ads that would contain both understandable risk information and benefit information. This box could contain published data including information on possible outcomes with and without the drugs. Many ads use vague qualitative terms to describe the benefits of a drug – the absence of actual benefit date may lead consumers to believe that a drug is more effective than it actually is. 
  • More disease awareness messages/communications without the promotion of a specific drug.  If we really want to improve public health, DTCA user fees should be employed to improve education on disease awareness, health conditions, diet, exercise, and medication adherence.  
  • Lastly, we support agency authority to place a moratorium on all DTC advertising for new drugs 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 also 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.

We look forward to FDA creating a robust and effective DTC user fee program as part of PDUFA V. 

2) Patient reporting of adverse events 

While we congratulate the FDA for working in PDUFA IV on improving the systems whereby consumers can report the problems with medical products, more needs to be done. If FDA wants to encourage voluntary consumer reporting of adverse events, the Agency must work hard to ensure that reporting mechanisms are consumer-friendly.

We have concerns, for example, about the ease of consumer reporting under the Medwatch online voluntary reporting  system. If you go online to try to report on Medwatch form 3500, the first thing you’re asked is to provide the “patient identifier.” What is this?  We’ve discouraged consumers from sharing personal information, including Social Security numbers. If it not a Social Security number, which appears to be the case, what is this number Medwatch is seeking?  If this is the first piece of information asked from consumers, they may be stopped in their tracks, and not fill out the form. We have to do better for consumers trying to report adverse events, and be sensitive to the fact that they might be managing a serious medical condition, and make the process as simple and welcoming as possible.    

In addition, all DTC ads, including those on the Internet should include the information on how to report an adverse event.     

3) Off-label prescribing   

NCL supports the comments of our consumer colleagues on this issue. 

PDUFA V presents an opportunity for the FDA to address some of the issues around off label use - to ensure these medications are used in a safe and appropriate manner, and that the consumer is informed.  From a consumer perspective, many people are likely unaware they are even being prescribed off label drugs.  A Wall Street Journal [iii] poll found that about half of Americans thought that a medication could only be prescribed for the disease for which it has been approved, demonstrating consumers’ lack of understanding of the current regulatory process.  Do consumers appreciate that off label prescribing exists? Do they have any idea how common it is?

Consumers should be informed about the following IF they are prescribed drugs off label: 

  • Availability of (indicated) alternatives
  • Body of evidence supporting product use
  • Duration/level of experience with proposed indication
  • Special population considerations
  • Approval status/use in other countries
  • Implications for insurance coverage

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

There are two additional points I would like to make:

  1. One is that NCL has a seat on the FDA’s  Risk Communication Advisory Committee, which is working to try to streamline and add clarity to the FDA’s communications about risks. The Committee, which is made up of academics, doctors, nurses, educators, health marketing specialists and consumer representatives, is developing recommendations for best practices in communicating risk effectively. We urge you to pay close attention to those recommendations when the Committee makes its reports.  
  2. Secondly, NCL has petitioned the FDA in June of 2008 asking that the agency  streamline the information consumers receive when they pick up a prescription, much of which is information currently FDA-mandated but nearly impossible for the average consumer to understand. NCL believes it makes more sense to provide a single clear patient-friendly document that will consolidate the many documents now in use and replace them with one that is easy to read, in plain language, in a consistent format, with plain instructions informing patients where they can reliably obtain additional information.

Thank you for taking the time to hear our views.


[i] “Promotional Spending for Prescription Drugs,” December 2009, CBO Brief.

[ii] Kaiser Public Opinion Spotlight, “Public and Physician Views on Direct-to-Consumers Prescription Drug Advertising

[iii] Wall Street Journal Poll – 2006

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