FDA Reaches Agreement with Drug Makers to Speed Up New Drug Review Times, Increase Fees for Oversight
The FDA and pharmaceutical companies have reached an agreement that may reduce review time for new drugs in exchange for tens of millions of dollars in new industry fees under the Prescription Drug User Fee Act, the AP/Richmond Times-Dispatch reports (AP/Richmond Times-Dispatch, 3/14). Under PDUFA, last renewed in 1997, the FDA charges drug makers a fee in exchange for an expedited review process. The law allowed the FDA to reduce the average review time for new drugs to less than one year in 1999, from about two years in 1990. The fees account for about 12% of the agency's budget (California Healthline, 1/28). PDUFA expires Sept. 30, and Congress has begun to debate legislation to reauthorize the law. The FDA yesterday sent lawmakers a letter that outlined the agency's agreement with drug companies, which would take effect if Congress renews the law. Under the agreement, the fees that drug makers pay under PDUFA would increase from $160 million last year to $223 million in 2003 and about $260 million in 2007 (AP/Richmond Times-Dispatch, 3/14). The agreement also would allow the FDA to use the fees to double the agency's staff of safety inspectors over five years to improve monitoring of new drugs after they reach the market (Bloomberg News/New York Times, 3/14). However, new FDA safety inspectors would monitor only drugs approved after Congress renews PDUFA, and post-marketing reviews "would be subject to separate agreements" between the agency and drug makers on a "case-by-case basis" and "would be limited to oversight" for a two-year period (Silverman/Cohen, Newark Star-Ledger, 3/14).
HHS Secretary Tommy Thompson called the agreement a "winning proposition for public health" that "is crucial to ensuring that Americans will continue to enjoy access to medicines that can lengthen and improve their lives" (HHS release, 3/13). Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that the agreement would help the FDA to maintain the "gold standard for regulatory agencies around the world" (Newark Star-Ledger, 3/14). According to Carl Feldbaum of the Biotechnology Industry Organization, the agreement would "benefit all concerned -- the FDA, the companies developing new therapeutics and, most importantly, the patients waiting for those new products." However, some drug safety advocates called the proposal "worrisome" and said that the FDA "already is approving drugs too fast and doesn't adequately monitor" the safety of new drugs that reach the market (AP/Richmond Times-Dispatch, 3/14). Bloomberg News/New York Times reports that the agreement may represent "an effort by drug makers to battle a perception that products are approved too rapidly at the expense of safety" (Bloomberg News/New York Times, 3/14). Opponents also said that the agreement would offer drug makers "too much say about how monitoring is conducted and too much power over the review of new drug applications." They added that negotiations between the FDA and drug companies "took place behind closed doors" (Newark Star-Ledger, 3/14).
Meanwhile, CongressDaily/AM reports that although aides to the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees have begun to review the agreement, some lawmakers have doubts (Fulton, CongressDaily/AM, 3/14). Rep. Henry Waxman (D-Calif.) said that the agreement "doesn't provide enough money" for drug safety (AP/Richmond-Times Dispatch, 3/14). According to Rep. Bart Stupak (D-Mich.), "The FDA is financially dependent upon an industry it regulates and because user fees are increasing dramatically, the dependence will grow significantly" (Newark Star-Ledger, 3/14). Rep. Sherrod Brown (D-Ohio) said that the "agency is cozying up too much to industry" in the agreement, but added that some of his concerns over the bills "could be assuaged" if "we can get decent enforcement language with real penalties." CongressDaily/AM reports that "how the legislation" to renew the PDUFA "will ultimately take shape this year is far from clear." Lawmakers may consider provisions in the legislation to reform medical device laws, increase the FDA's role in oversight of drug advertising, expand the FDA's power to monitor drugs, increase penalties for drug companies that do not comply with FDA rules and reform drug patent laws. House Energy and Commerce Committee Chair Billy Tauzin (R-La.) has asked lawmakers not to "load PDUFA with additional items," and the Senate Health, Education, Labor and Pensions Committee may attach the PDUFA reauthorization bill to a separate anti-bioterrorism legislation to "avoid bogging the bill down," CongressDaily/AM reports (CongressDaily/AM, 3/14).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.