The number of novel drugs that won government approval last year remained flat at 18, further evidence of a decade-long stagnation in the quantities of new medicines reaching patients.
The tally includes only those drugs that contain chemical ingredients never before sold in the United States. Among them are prescription drugs to treat diabetes and help smokers quit, and a new nonprescription sunscreen ingredient to better block the sun’s damaging rays.
Also on the 2006 list: four new vaccines, the most such approvals in any recent year, including shots to prevent shingles and cervical cancer, according to Washington Analysis, which released its count of FDA approvals this week. Four protein-based drugs also won approval.
The overall stagnation comes despite steady increases in drug industry spending on research and development, and amid much-touted efforts by the Food and Drug Administration to speed more drugs to market. So far, those efforts have failed to buck the general decline since 1996 in the numbers of drugs to receive FDA approval each year.
“My sense is that there really is a shortage of applications” from drug companies, said Ira Loss of Washington Analysis. “They are only inching along, pending the next big breakthrough.”
The Pharmaceutical Research and Manufacturers of America said there are more than 2,000 potential new drugs now in development, the most ever.
“The number of compounds that continue to go into clinical testing is increasing. While the current year’s number is a little bit low compared to what might be termed historical trends, our view is the research enterprise is still vibrant,” said the industry group’s Alan Goldhammer.
That implies the downward trend won’t hold, said Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development.
“The industry is beginning to fill its clinical pipeline, which would suggest down the road, we will see a rebound in the total number of products reaching the marketplace,” Kaitin said. Such a recovery could take as long as seven years to reach patients, however.
Nor has the development of new drugs kept pace with increased research and development spending, according to a Government Accountability Office report issued in December. Between 1993 and 2004, R&D spending by drug companies grew 147 percent, to $39 billion, while the number of novel drug applications grew just 7 percent, the GAO found.
The drug industry faces problems translating research discoveries into new medicines, government auditors found. Companies also remain focused on churning out new blockbuster drugs that can rack up $1 billion or more a year in sales, to the detriment of the development of less lucrative but still innovative medicines, according to the report.
Drug development experts and others interviewed by the report’s authors said companies frequently halt development of drugs that could fall short of annual sales targets once approved and on the market.
That strategy may fall by the wayside: Kaitin said last year’s ouster of Pfizer Inc.’s chief executive, Henry McKinnell, was in part a repudiation of the industry’s blockbuster-or-bust philosophy.
“What the investment community is saying is we want to see more diversity in your portfolio, more focus on niche products,” Kaitin said.
The industry as well has focused on so-called “me-too” drugs that are similar to other medicines already on the market, according to the GAO. While less risky to develop, they don’t provide the significant benefits that true breakthrough drugs can, according to the report.
An example cited by one expert is the final novel drug to win FDA approval in 2006: Johnson & Johnson’s paliperidone. Both the company and FDA touted the schizophrenia drug, also called Invega, as new. However, Invega is derived from another J&J drug, Risperdal. Risperdal breaks down in the body to form paliperidone.
That makes the drug neither a major breakthrough nor a totally new substance, said Dr. Grant Mitchell, chief of psychiatry at Northern Westchester Hospital in Mount Kisco, N.Y.
“To me, it appears to be a tweak — not an unwelcome tweak — but we’re not going to see any revolution in the treatment of schizophrenia because of this drug,” Mitchell said.
There should be some cause for optimism among drug makers, especially with the advent of new screening and other technologies that can reduce the number of drugs that fail late in development, according to the Tufts Center for the Study of Drug Development.
Those late-stage washouts can cost industry plenty. In December, Pfizer said it had halted development of its cholesterol treatment torcetrapib because of safety concerns. It had spent $800 million on the drug.
More outsourcing and greater coordination among international regulators also should help speed the development and reduce the costs of new drugs, according to a January report from the Tufts center.