The Food and Drug Administration has often been accused of dragging its feet in getting new drugs on the market. But in 1985, after a last-minute sprint to the finish line, the agency approved a record number.
The final 1985 count totaled 30 new drugs that were chemically different from those approved in the past. The agency touted this as eight more than in 1984 and the largest number of such approvals in any year since 1962 legislation requiring that drugs be reviewed for effectiveness as well as safety.
FDA records show that the record was set as the new year approached, with 16 of the 30 new drugs given final approval after mid-December.
FDA Commissioner Frank E. Young said there was also an "all-time record" in approving drugs that offer treatment advances over existing drugs. The FDA gave three of the drugs -- a drug for young children with severe respiratory infections, a genetically engineered growth hormone for children and a drug for severe heart patients -- an A rating, representing a "significant increase in therapeutic gain."
Fifteen others got a B for "moderate increase," including an antihistamine that does not usually cause drowsiness and a drug for fighting the nausea caused by anticancer drugs. The rest offered no therapeutic advance over existing drugs already on the market, according to the FDA.
Newly appointed Health and Human Services Secretary Dr. Otis R. Bowen issued a press release saying that the record number of approvals "shows the results of vigorous and productive research by our pharmaceutical industry as well as improved cooperation between government and the private sector under the Reagan administration."
Improving and speeding up the drug approval process has been a top priority at the agency since Reagan took office. But a massive overhaul of the system has taken longer than originally promised. New regulations are only now going into effect, and a long-anticipated proposal for revising procedures for investigating new drugs has still not appeared.
Instead, say FDA officials and outside observers, recent internal changes at the agency have greatly improved the climate for approving new drugs but have not yet resulted in a dramatic change in the time it actually takes to approve a new drug -- about 24 months on average.
And although a record may have been set last year, the number of totally new drugs is not dramatically different than in past years. Indeed, there have been repeated fluctuations over the past 15 years.
There was a jump from 12 in 1980 to 27 in 1981, up only slightly to 28 in 1982, down to 14 in 1983 and back up to 22 in 1984. In the 1970s the numbers also varied annually but were somewhat lower overall, with a low of 10 in 1972 and a high of 24 in 1976.
Critics say that the total number approved in a given year is not particularly significant in and of itself, since it is easy, as one source noted, "to make any one year look good by robbing from the following year."
Dr. Sidney Wolfe, of the Nader-founded Public Citizen Health Research Group, raised questions yesterday about the year-end rush to approve drugs in 1985. "Something's wrong when half of the ones approved get approved in December. It makes me think they are more intent on piling up numbers of approved drugs for 1985 than adequately protecting the public from unsafe or ineffective drugs."
"It's beneath him to suggest that," responded Dr. Robert Temple of FDA's Center for Drugs and Biologics. "I want to say unequivocally there isn't anyone who skips any step in the process."
Temple said that "the many actions in December represent tremendous efforts well before that." While many of the time-consuming reviews that make a drug ripe for approval are completed in earlier months, he said, give-and-take between the agency and individual companies that allows the action to become final often speeds up at years end.