US drug makers raise new concern on FDA review delays

06 February 2001 19:16  [Source: ICIS news]

WASHINGTON (CNI)--The pharmaceutical industry expressed renewed concern Wednesday about the amount of time the US food and Drug Administration (FDA) takes to approve prescription drugs with new active ingredients.

Drug industry officials contend there has been a "dramatic" increase in approval times at FDA. But FDA officials counter that much of the delay may be due to slow response times by the drug makers themselves.

Industry officials say that in 2000 FDA ended a seven-year streak of faster approval times, granting approval to 27 new drugs in 2000 after an average review period of 17.6 months. In 1999, by comparison, FDA cleared 35 drugs with an average review time of 12.6 months.

The length of time it takes FDA to approve new drugs had fallen significantly since 1993, sources note, after Congress passed the Prescription Drug User Fee Act of 1992, a federal law designed to speed up the agency's review process.

In 1993, FDA took an average of 26.5 months to approve new drugs. But the agency had steadily picked up the pace, cutting drug approval times in half by 1999.

Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), said of the FDA's pace: "This slowdown in the review time of new drug approvals does concern us because it means that patients have to wait longer for medicines that could help them."

"Given the explosion of research that the mapping of the human genome is making possible," Holmer noted, "there will be many more drug candidates in the future. That's why it's critically important to patients that FDA review them in a timely manner."

While the 1992 law does not impose drug-approval deadlines on FDA, it does generally oblige the agency to complete its review of a new active ingredient within one year, or within six months for "priority review" drugs that have a new method of action or have clear advantages over existing medicines.

A PhRMA spokesman said FDA continues to approve "priority" drugs in six months or less, but approvals for other medicines are slowing as agency reviewers increasingly request additional clinical data from manufacturers about the safety and effectiveness of their products.

But Janet Woodcock, head of FDA's Center for Drug Evaluation and Research in Rockville, Maryland, argues that the agency is meeting mandated review time requirements. Although approval times slowed for new pharmaceutical compounds last year, she said, FDA met all of the goals imposed by the 1992 law, including reviewing half of all original new drug applications within 10 months.

"The FDA has met all of our goals. In fact, we exceeded them," Woodcock said. Average drug approval times may have increased for reasons beyond the agency's control, she suggested.

In 1999, Woodcock said FDA approved more applications on the priority review track than it did last year. But she said fewer drugs fit in that category in 2000, which increased the average drug review time.

"Since there were so many more standard reviews, the time went up," Woodcock said.

In addition, the FDA official acknowledged that review times may have increased as the agency asked drug makers to supply more information. In some cases, it took companies "many, many months" to answer FDA's questions, Woodcock said.

By: Glenn Hess
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