Reprinted Articles

Letter in Support of Increased FDA Funding

Center for Medical Consumers
Consumer Federation of America
International Union, UAW
National Center for Policy Research for Women & Families
National Organization for Rare Disorders
National Women's Health Network
Public Citizen
Title II Community AIDS National Network

June 24, 2002

The Hon. Henry Bonilla
Chairman
House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies
Washington DC 20515

Dear Mr. Chairman and Committee Members:

We are writing to ask your support for increased funding for the Food and Drug Administration. We believe that without increases in the FDA’s budget, the agency’s ability to protect the safety and health of the American public will be seriously compromised.

The President has requested an increase in the FY2003 FDA budget of $123 million, or 8 percent, over FY2002. While we support the request for an increase, we do question whether the $123 million additional is sufficient to enable the agency to satisfactorily carry out its responsibilities to protect the public health. Therefore, we urge you to consider increasing FDA funding beyond the amount requested by the President.

The following describes specific concerns we have with the proposed FDA budget.

1. Additional funds for drug post-marketing safety [PS] activities.
Unfortunately, the short duration and small number of participants in the clinical drug trials required for FDA approval dictate that the toxicity of a new product cannot be fully understood when a drug is approved and initially marketed. It is absolutely critical for the public’s safety that FDA’s programs for post-marketing surveillance be modernized and strengthened. A voluntary, reactive program will not adequately protect the public from preventable harm, especially considering the well-known problem of under-reporting of adverse drug reactions.

Despite the FDA’s own admission that its drug/biologic surveillance is “severely challenged” and that “critical new drug safety work is not getting needed funding”, the testimony of FDA Deputy Commissioner Lester Crawford before the House Committee on Appropriations, Subcommittee on Agricultural Rural Development, FDA and Related Agencies [3/21/02] is devoid of any significant advancements in PS. The primary reason for this deficit is a lack of funds.

We believe that the proposed FY2003 budget increase of $2.2M [1] is not sufficient, even when coupled with the new user fees and the “reserve” created pursuant to the recently-passed Title V [Prescription Drug User Fees] of the BioTerror [BT] bill. In a meeting earlier this year, members of the Coalition were told by FDA officials that about $100M in extra funds is needed to do good PS activities--this includes medical devices and proper oversight of drug marketing practices, as well as drugs

The FDA is claiming that it had a productive round of PDUFA III negotiations with industry which successfully addressed its “risk management” [safety] goal. We disagree:
1. Post-market safety [PS] activities is limited--estimated at no more than $20M [in FY2007] out of approximately $100M[FY2007] in additional fees; and
2. More significantly, those fees can only be used on drugs approved after October 2002 and only for, at most, a period of 3 years post-approval.

Thus we are once again in the situation of relying on appropriated funds to conduct the majority of needed safety activities.

The Congress did in Title V of the BT bill order the Secretary to reserve for the Office of Drug Safety from appropriated funds an extra $5M in FY2003 and an extra $10M in FY2004, adjusted upward after 2004 for inflation. We welcome this development, but unless sufficient new funds are appropriated, the FDA will be forced to siphon those funds from other worthy programs.

It is not the case that there is a lack of ideas about how to improve PS. [2] The FDA simply lacks sufficient resources to implement the depth of programs necessary to prevent injury and save lives.

As the final responsibility for the public’s health and safety rests with Congress, we ask that you appropriate additional funds and include report language directing the use of such funds for active and comprehensive PS activities including the use of targeted clinical trials, registries, operation of sentinel systems, prospective comparative safety assessments and the like.

2. Additional funds for medical devices
The President's budget proposal requests an increase of nearly $5.2 million for pay increases for the medical devices program, but only $1.5 million for improvements in patient safety programs. This increase is obviously inadequate to address many of the serious deficiencies in the current medical devices program. Among the tasks of the Center for Devices and Radiological Health (CDRH) that suffer from inadequate appropriations are the inspection of medical device manufacturing facilities, the monitoring of adverse events, the monitoring and implementation of post-market safety commitments, and the enforcement of required post-market surveillance activities.

We believe that an increase of $15 million (instead of $1.5 million) is necessary for medical device safety programs. Additional funds, approximately $25 million, could be devoted to improving the timeliness of the review process for new medical device marketing applications -- making unnecessary the third-party inspectors and reviewers sought by industry

Currently, the CDRH lacks the resources to inspect all medical device manufacturing facilities in a timely manner. Frequently, facilities will go 7 or 8 years in between inspections. With over 70,000 facilities under its purview, the CDRH is in desperate need of more funding for this basic and essential safety function.

Likewise, the CDRH has an inadequate staff for monitoring adverse events and will need more appropriations to implement and enforce its new June 2002 rule requiring post-market surveillance activities for up to 30 new medical devices a year. Part of the proposed $15 million addition for medical device safety is urgently needed to monitor devices already on the market.

To meet some of these funding needs, industry advocates have pushed for legislation that permits industry to directly contract third-party inspectors and reviewers -- presenting an intolerable financial conflict of interest. Clearly, patients and consumer safety is undermined unless the funding needs of the CDRH are met instead with additional appropriations -- approximately $15 million for medical device safety and $25 million for medical device review.

3. Additional funds, as authorized in the BT bill, to enable the FDA to better monitor direct-to-consumer (DTC) prescription drug advertising.
The FDA suffers from a critical lack of resources to protect the public from misleading prescription drug ads that oversell the benefits and underplay the risks of the products being promoted. We note that as part of the BT bill, Congress authorized increases to DDMAC of:
2003: $2.5M
2004: $4M
2005: $5.5M
2006: $7.5M
2007: $7.5M

We support this authorization and appropriation.

Since 1997, when the FDA relaxed its rules, DTC advertising has skyrocketed. In 2001, drug companies spent more than $2.6 billion on direct-to-consumer advertising in comparison to 1997 when DTC ad spending totaled less than $800 million. In spite of this dramatic expansion of advertising, FDA enforcement actions against ads which violate the agency’s standards have dropped off: in 1997 FDA issued 139 warning letters about DTC ad violations and in 2001 it issued only 73.

While the FDA requires DTC ads to be scientifically accurate and provide a fair balance of risks and benefits, it lacks the necessary resources to assure that companies comply. The newly authorized funds are critical for strengthening the agency’s capacity to identify and respond to violations in a timely way.

Slow action on inaccurate and incomplete advertisements is a serious problem for consumers. Until the agency informs a company that it must withdraw or change an ad, the public will continue to be exposed to false information and to ads that fail to include important risk information. Delays in this area pose an unacceptable threat to the public health.

In addition to more staff, there is a dire need for DTC-specific regulations since, other than the late 1990's guidance concerning broadcast advertising (which is a guidance not a regulation), there are no regulations specifically written for DTC advertising. The FDA has been using the regulations promulgated after the 1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act that were clearly intended for prescription drug advertising directed at health professionals such as doctors and pharmacists. Public interest groups have been urging the agency since the mid-1980s to develop consumer specific DTC regulations which would make it easier to evaluate the ads in the context of patient, not health professional, comprehension.

4. Additional funds, as authorized in the BT bill, to bring generics to market faster
The President’s budget proposal includes $4.6M in additional funds to expand the “generic drugs program by hiring additional product reviewers, plant inspectors, and to more closely monitor the quality of imported generic drugs and bulk drug substances. According to the Crawford testimony, the increase will “allow FDA to review and act upon 75% of fileable original generic drug applications within 6 months.”

In addition, in the BT bill, Congress authorized to the Office of Generic Drugs increases of:
2003: $3M
2004: $6M
2005: $9M
2006: $12M
2007: $15M.

According to the Manager’s Statement, this increased funding is “due to the fact that it presently takes OGD nearly 18 months to review the typical ANDA.”

We support this authorization and appropriation.

Consumers need relief from high drug prices. The first generic on the market is typically prices 20 to 30 percent below the comparable brand name. As more generics enter the market in a therapeutic category, prices fall further.

5. Additional funds to improve the protection of human subjects in research and the integrity of research data in clinical trials.

In light of the reported deaths of human research subjects in recent years, there appears to be general agreement that the decades-old reliance on Institutional Review Boards (IRBs) to protect human subjects in research is not working to protect all human subjects. In addition, multi-site research focused on new, complex therapeutic products is growing, creating more complicated trial designs that enroll ever-larger numbers of increasingly diverse participants.

If we are to ensure that biomedical research moves forward, vulnerable populations are protected, and Americans continue to willing participate in clinical trials, steps must be taken to protect the welfare and safety of all human research subjects. We agree with Dr. Greg Koski, Director of the HHS Office of Human Research Subject Protections that, "the ethical framework in which we conduct research requires that we carefully consider the risk and potential benefits associated with research as we decide whether or not to pursue a particular study." [3]

Although the FDA, for its part, has identified the need to increase the number of inspections and to perform better oversight of IRBs, we urge that an office of bioethics be established within the FDA to make certain that the highest ethical standards are met.

While we are pleased that the FY2003 budget proposal does address FDA resource issues critical to the public health, we urge that the FDA’s proposed funding be increased beyond the $123 million requested by President Bush. If it is not, we fear that the agency will not be capable of successfully carrying out its legal mandates to protect the public health to the degree necessary to assure the safety and efficacy of drugs, biologics and devices.

Thank you for your attention to these important public safety issues.

Center for Medical Consumers
Consumer Federation of America
International Union, UAW
National Center for Policy Research for Women & Families
National Organization for Rare Disorders
National Women's Health Network
Public Citizen
Title II Community AIDS National Network

cc: The Hon. Marcy Kaptur Members, House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies

EndNotes
[1] The President has proposed an additional $5M in FY2003 for "patient protection"-related issues. This $5M is to be divided among drugs [$2.2M], biologics [$1.3M] and devices [$1.5M].
[2] For suggestions on how to improve PS, see the PDUFA III proposal of the FDA’s Office of Drug Safety, the recommendations in the 1999 report of the Inspector General of HHS ["Review of the Food and Drug Administration's Handling of Adverse Drug Reaction Reports"], and scholarly articles including:
-Wood, Stein, Woosley et al, NEJM 12/17/98—proposing a PS program independent of FDA and calling for an Independent Drug Safety Board [like NTSB is to FAA];
-Moore et al JAMA 5/20/98—outlining suggested tasks for FDA’s office in charge of drug safety; and
-Woosley [GAO/DIA, 2/24/99]--outlining a “broad spectrum approach” to PS assessment:
[3] Journal of Law, Medicine and Ethics, 28 (2000): 330-331