FDA approval times expected to lengthen

Recent controversies over the safety of drugs already on the market may mean that medications not yet approved will have to go through a longer regulatory approval process, according to experts quoted by the Associated Press.

Questions have been raised in recent months concerning the safety of a drug for multiple sclerosis, the COX-2 inhibitors and other pharmaceuticals. These events have led some to believe the country is “in for a dramatic slowdown in the approval process as the Food and Drug Administration wants to see more extensive trials and data,” according to Jason Napodano, an analyst at Zack Investment Research quoted by the AP.

It may be that the slowdown in approval times will originate with independent reviewers rather than FDA employees, the AP article suggested.

The average time to approval for a medication was 12.6 months in 1999, and this figure has now risen to about 17 months, according to data from the Pharmaceutical Research and Manufacturers of America quoted by the AP.

Pharmaceuticals that fall into new classes of drugs or those entering disease fields that are already crowded are likely to be most heavily affected by the slowdown, the AP reported.

In other FDA news, the agency requested from Congress the authority to dictate labeling changes for drugs.