More funding needed for post-marketing drug safety



October 7, 2005
The Honorable Joshua B. Bolton
Director
The Office of Management and Budget
725 17th Street NW
Washington, DC 20503
Dear Director Bolton:
As you prepare the fiscal year 2007 budget for the U.S. Food and Drug Administration, Consumers Union, the independent, non-profit publisher of Consumer Reports, believes that the agency is under-funded for the critically important, ever-increasing consumer protection tasks it faces. We hope that you will specifically provide additional resources and authorities above baseline for the following currently underserved areas:

  • increased monitoring and enforcement of various pre- and post-market approval safety issues;

  • pre-approval of direct-to-consumer and other marketing materials and enforcement of marketing regulations; and
  • analysis of the drug and medical use data which will be available from the new Medicare Part D program and which can provide a major new database to detect short- and long-term safety problems in the use of pharmaceuticals.

In terms of drug approval and safety, between FY 2005 and 2006, the appropriations request was basically flat and did not keep pace with inflation. While there were increases in available user fee funds, those funds are generally dedicated to meeting certain approval targets. Therefore, we hope that in FY 2007, there will be a larger commitment to drug and medical device safety.
Attached are details on why additional resources in these areas are needed.
In addition, Consumers Union strongly endorses legislation such as S. 470, S. 930, HR 3196, and HR 3696 to give FDA more definitive authority to require the registration and publication of clinical trials, ensure postmarket safety programs, moderate the advertising of newer, relatively unproven drugs, and in general give more organizational attention to postmarket safety. If the First Session of the 109th Congress does not act in these areas, we hope that the Administration will include support for these proposals in its FY 2007 budget request. But without increased resources — either increased direct appropriations or dedicated user fees — increased authority will be a hollow promise.
As an example of the possible need for additional resources, we include a copy of The New York Times report of September 12, 2005 entitled “FDA Had Report of Short Circuit in Heart Devices.” The issue involves the unacceptable delay in reporting serious, deadly defects in heart defibrillators. The company was slow in reporting the defects. But what is unclear is whether the FDA failed to read and/or recognize the reports of defects once they were reported. As the Times wrote,
“While the agency has a policy of reviewing the reports within 90 days, it is unclear when regulators did so within that time frame….
We urge you to determine whether the agency has the resources necessary to read and analyze data as it arrives, and if not, to help assure such resources are available as soon as possible. We note that the Times article contains some discussion of key data being lost in mountains of background material. If that is part of the problem, we urge the Administration to require a revision of the data submissions to ensure that the information arrives in a way that the agency can more readily use to immediately identify and report safety problems.
We thank you for your consideration and look forward to working with you on behalf of a more effective FDA that can protect the American public from the type of drug safety problems that have occurred in the past.
Sincerely,
William Vaughan
Senior Policy Analyst
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Increased monitoring and enforcement of various pre- and post-market approval safety issues

Consumer Reports believes that more resources need to be given to both the registering and monitoring of clinical trials and to post-market approval.
Only if clinical trials are reported and disclosed can the public understand all aspects of a drug’s safety. The agency reported to Congress on August 12 that despite the law and regulations, the industry on average was still not registering and reporting an adequate level of clinical trials. Staff is needed to enforce the requirement of registration and reporting. A number of FDA employees have said that the timeframes for new drug approvals under PDUFA are so tight, that there are not enough resources to ensure that drugs reaching the market are safe. As one FDA drug safety manager testified before the Institute of Medicine on July 20th,
“None of my offices report to me that they have enough people to do all of the work they’re charged to do.”
If drugs are entering the market with unanswered safety questions, it is more important than ever that the Office of Drug Safety have more resources to ensure follow-up studies, ensure appropriate risk management, and collect and analysis adverse effect reports.
It appears that as many as 68% of drug company promises for post-market approval studies have not even been started. Staff needs to be available and dedicated to the task of ensuring that these commitments are met, and if not, why not.
Adverse Event reports have climbed from 322,694 in calendar year 2002 to 422,889 in 2004, while the office that reviews these reports appears to have had little or no growth. While an increasing number of these Adverse Event reports are submitted electronically, which improves productivity and is less expensive for the agency to handle, this is still a phenomenal growth in workload. What is worse is it is clear that most adverse events do not get reported. It appears that in some cases, companies have misclassified or delayed in reporting adverse events. The agency needs to do more in this sector to prevent future examples like the Guidant case.
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Increased resources for pre-approval of marketing materials and enforcement of marketing regulations

Most of the pharmaceutical industry has just adopted voluntary standards calling for pre-marketing approval of direct-to-consumer (DTC) advertisements. While Consumers Union supports Senator Frist’s call for a two year moratorium on the advertising of new drugs, and endorses legislation such as S. 930 and HR 3696, that would require such prior review during the years immediately after a drug’s approval, the industry’s action is a step in the right direction. Will the FDA have the resources to review these ads on a timely basis? If not, the industry’s effort is likely to wilt away.
While the level of DTC advertising has exploded in the last 8 years, the number of warning letters has trended downward. We believe that the FDA has not been doing an adequate job in this area; see the enclosed Consumer Reports article of February, 2003 that documents the repeated violation of public safety standards in DTC. We understand that the office of drug-marketing enforcement has only about 40 employees to review more than 30,000 pieces of promotional material per year. The industry’s voluntary effort to seek more pre-approvals will just put more strain on the system. One House appropriator has urged that the funding for this activity be doubled (and that there be no DTC for three years after a drug is first approved).
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Is the FDA prepared to utilize the data that will soon be available from the Medicare Prescription Drug Program and from e-prescribing?

We urge that the FDA have the resources to utilize the extraordinary data base that will be available as the new Medicare Prescription Drug Program begins.
We support the current the FDA contracts to utilize the database of large insurers, such as Kaiser Permanente, to detect drug interactions and favorable and unfavorable effects. The Medicare Part D database will offer a tremendous new opportunity (about four times larger than the current, contracted databases) to understand the impact of drugs on seniors and people with disabilities—a group that all too often is not included adequately in the clinical trials.
Is the FDA prepared to receive and, more importantly, massage this data to detect short- and long-term drug safety issues? Similarly, the new database can help the nation understand the comparative effectiveness of different drugs and drug/medical treatments. It can be a tremendous supplement to the work of AHRQ and the implementation of section 1013 of the Medicare Modernization Act.
In addition, the company of health information technology, personal electronic medical records, and e-prescribing as part of the MMA will also enable appropriate groups to reach out to patients to periodically ask about adverse drug events and ensure better risk management. The current adverse event reporting system catches somewhere between 1 and 10 percent of possible problems. With the emerging technologies, the FDA should be preparing to greatly increase its ADE monitoring, moving from a passive system to an active system that will catch many more problems at an earlier date.
As part of the FY 2007 budget, we hope that the administrative, technical, and professional staffing will be available to take full advantage of this new database.