Food and Drug Administration Protecting Drug Industry, FDA, FDA Protecting Drug Industry, PDUFA, FDAMA, FDA User Fees

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and effectiveness of medicines.

In recent months, the FDA has received and continues to receive negative media attention related to drug safety issues.
In late 2005 a FDA whistleblower accused the FDA of shifting to a pro-drug industry position.
The FDA was accused of deliberately hiding the link between anti-depressants and adolescent suicides.
It took more than four years, and more than 100,000 deaths to pull Vioxx off the market, and the company, rather than the FDA, initiated the withdrawal.
Drugs with known deadly side-effects that have been withdrawn by other countries remain on the market in the U.S.
After 60 years of looking the other way regarding allowing the personal importation of lower cost medications, the FDA is now aggressively siding with the drug companies' profit motives to minimize lower cost medication imports.

I am convinced by my research that the events listed above and other recent pro-drug industry FDA changes can be, in part, explained by the influence of drug industry money (i.e. hundreds of millions of dollars) paid yearly to the FDA. For a complete copy of the study, click on "Thesis" on side panel.

Since, the Food and Drug Administration (FDA) began requiring applicants to pay significant user fees when filing applications in connection with new medical devices and biologics. Such user fees have long been required for drug-related applications, and now also are required for applications related to devices and biologics. In theory, user fees enable FDA to speed up application review time, but at what cost? User fees impose a significant financial burden on many biotechnological companies that produce regulated products, and the fees actually may not improve overall efficiency.

User fees provide the FDA with resources to hire additional reviewers in order to accelerate application reviews. However, FDA’s review of applications is only a small component in the lengthy product approval process. Many other actions, by both FDA and applicants, profoundly affect product approval time. Typically, the Food And Drug Administration requires a sponsor to submit several applications in sequence. Sponsors first submit applications for a series of clinical trials, and later, applications summarizing clinical evidence of safety and effectiveness. The weeks FDA spends reviewing any of these applications pales in comparison to the months, or even years, a sponsor may spend responding to FDA concerns, requests for additional clinical and non-clinical data, and facility inspections. Thus, improving efficiency in reviewing applications does not necessarily speed up the overall product approval process.

User fees may, in fact, be creating new problems. Large businesses can readily afford the substantial fees for filing applications with FDA, but to smaller firms, these fees are a sizeable burden. Consider, for example, that user fees can cost a sponsor of a new drug over $500,000 for a single application, and the fees associated with new medical devices and biologics can exceed $150,000. The strain on smaller businesses is significant, and an unintended consequence of user fees may be to weaken innovative start-up companies. Moreover, user fees have created a two-tiered review system, where FDA reviews fee-based applications preferentially. Although not every application requires a user fee (and smaller businesses should become familiar with these exceptions), FDA reviews fee-based applications first, before moving to applications that are exempt. Thus, user fees may not only be putting small companies at a competitive disadvantage, they may provide a disincentive for FDA to review important, but not fee-based, applications efficiently.

There is no doubt that the number of reviewers at FDA affects review times, however, there also is much other inefficiency within the agency. Recently, the directors of each of FDA’s Centers lamented that the Agency’s information management is woefully inadequate. Information is hoarded locally, and generally not shared across organizational lines. This may be because sharing information does not advance one’s career at FDA, whereas personal knowledge does. There are many other sources of inefficiency as well, including Congress’ addition of responsibilities to the Agency without providing more financial support. Although most businesses in FDA-regulated industries would welcome quicker product approvals, user fees alone will not solve the major inefficiencies at the Agency, but the fees are most likely an unethical, misuse of government funding by big business to control the Food And Drug Administration and minimize competition by smaller, up start biotech corporations.

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