By Kim Coghill

Washington Editor

WASHINGTON ¿ The pressure to approve drugs quickly has created a sweat shop atmosphere within the FDA, and could threaten the safety of the public, a House subcommittee heard Thursday.

Abbey Meyers, president of the National Organization for Rare Disorders, criticized the Prescription Drug User Fee Act of 1997 (PDUFA II), saying it has the potential to severely affect the public.

¿Products are being rushed through the review process, and as a result, consumers are being exposed unnecessarily to sometimes dangerous and life-threatening drugs,¿ she said in testimony. ¿When FDA determines that a drug is both safe and effective, we take them at their word.¿

She also blames PDUFA for problems within FDA.

¿For each new drug application submitted to the FDA, reviewers must master volumes of data in less than six months or a year, while juggling many other tasks,¿ she said. ¿They quickly burn out from the intense pressure to perform, and often leave the agency in less than two years and go to industry to earn higher salaries.¿

The debate over whether PDUFA should be reauthorized is slowing beginning to pick up steam, as industry representatives on either side of the issue line up to dissect the law and air their opinions.

In the first of probably many such meetings, the House Energy and Commerce Health Subcommittee heard arguments on the effectiveness of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which reauthorized PDUFA for another five years.

PDUFA II, which expires at the end of next year, authorizes the FDA to collect user fees from companies that produce drugs and biologics in order to pay for additional staff and technology. When PDUFA was initially approved in 1992, the FDA had 1,277 drug reviewers. Today the number is double that.

¿FDAMA represents an effort to have industry and government work more collaboratively in order to speed the decision-making process, and it represents an effort to get better information in the hands of patients, doctors and consumers,¿ said Rep. Billy Tauzin (R-La.), chairman of the House Committee on Energy and Commerce.

The median total approval time for new drug and biologic applications submitted in fiscal year 1999 dropped to 11.6 months, from 20.1 months in fiscal year 1994. Given the progression of PDUFA II review goals, median total approval times could drop to 10 months in fiscal year 2001 or 2002 if the current rate of first review cycle approvals is sustained, Linda Suydam, senior associate commissioner at FDA, said in her testimony.

¿Not only has FDA significantly reduced review times as a result of the PDUFA programs, but it also has significantly reduced approval times, and therefore the time it takes to get new drugs to the market,¿ Suydam said.

But Meyers argues that the fast pace isn¿t necessarily a benefit. In fact, it could be argued that rushing through the approval process has led to withdrawals of marketed drugs. ¿The publicity fueled by these withdrawals has further cast doubt on whether the user fee program is in the public¿s best interest,¿ she said.

Since PDUFA was approved in 1993, seven drugs have been removed from the market due to severe adverse reactions and deaths. ¿Not one of these pharmaceuticals was a life-saving drug,¿ she said. ¿They were drugs for heartburn, diabetes, irritable bowel syndrome, a painkiller, a blood pressure medicine, an antibiotic and a diet pill. There was absolutely no reason to rush them to market.¿

For example, last March Parke-Davis/Warner-Lambert agreed to the FDA¿s request to remove Rezulin (troglitazone) from the market. The drug, used in the treatment of Type II diabetes mellitus, caused severe liver toxicity.

¿Products are being rushed through the review process and, as a result, consumers are being exposed unnecessarily to sometimes dangerous and life-threatening drugs,¿ Meyers said.

Drugs are now reviewed in the U.S. as fast or faster than anywhere in the world, without compromising the very stringent standards that Americans have come to expect, Suydam said. In the past seven years, pharmaceutical firms have introduced 234 new molecular entities into the market ¿ a sizable increase over prior decades. Although European pharmaceutical companies dominated the industry 10 years ago, U.S. companies now have an overwhelming lead in world markets, she said.

In biotechnology, the FDA in 2000 approved products that delay the time to disease progression in malignant osteoporosis; reduce the signs and symptoms of rheumatoid arthritis in patients with inadequate response to methotrexate; and delay structural damage in patients with moderately to severely active rheumatoid arthritis.

Meyers asked subcommittee members, before reauthorizing FDAMA, to consider that the act was approved during the Clinton administration, and some suspect it fell victim to the idea of reinventing government initiative.

¿Congress wanted to cut back federal spending, so user fees were implemented,¿ she said. ¿Many consumer groups opposed FDAMA because they felt it would lower the safety and efficacy standards for new drugs, inflate the FDA¿s resources for new drug reviews and, in turn, deflate resources in other areas of the agency.¿

Travis Plunkett, legislative director of the Consumer Federation of America, said that, as a result of the 1992 and 1997 legislation, the FDA has increased the amount of resources it devotes to new drug and biologics review and approval from $120 million in 1992 to a projected $325 million in fiscal year 2002.

¿It is estimated that a record half of the resources required for new drug approvals will come from user fees paid by the regulated industry,¿ he said. Plunkett charged that PDUFA creates a financial dependency by the FDA on the industry it regulates. ¿This is a conflict of interest that could compromise drug safety,¿ he said.