Pharmaceutical companies say new approach by FDA has led to decrease approvals of new medications

An "intensifying focus on safety and a diminished tolerance for side effects" by FDA have "dramatically lowered" the chances that experimental medications will reach the market and have led to a recent decrease in approvals of new treatments, according to pharmaceutical companies, the Wall Street Journal reports.

Last year, FDA approved 19 new medications -- the fewest in 24 years -- and announced about 75 new or revised "black box" warnings, twice the number announced in 2004, according to a division of Sagient Research Systems. In addition, the number of approvable letters, which in most cases require pharmaceutical companies to submit additional clinical data before FDA will make a decision on whether to approve experimental medications, increased by 40% last year.

Schering-Plough CEO Fred Hassan said that the company has ended development of two experimental medications with the potential to become blockbusters because of the new approach by FDA.

Ira Loss, a health care analyst at Washington Analysis, said, "There is no question that the FDA is more safety-oriented than it has been in years," adding, "Regulation tends to be a pendulum, and a series of things, the most dramatic of which was Vioxx, has sent the pendulum back in the direction of safety." Kenneth Kaitin of the Tufts Center for the Study of Drug Development said, "Everything pointed to the notion that FDA and the industry had lost their compass and that the FDA needed a course correction." He said that, with the new approach, FDA is viewed "as an agency that is supposed to keep unsafe drugs off the market, not to speed access to lifesaving drugs."

However, Janet Woodcock, director of Center for Drug Evaluation and Research at FDA, said that the agency has not become "more conservative" and that the decrease in approvals of new medications has resulted from a lack of positive results in research conducted by pharmaceutical companies. She said, "You can't approve drugs you don't get applications for" (Johnson/Winslow, Wall Street Journal, 6/30).

Diabetes Medications

In related news, FDA officials and outside medical experts on Tuesday will participate in a special two-day meeting to discuss whether pharmaceutical companies should have to conduct studies to prove that diabetes medications reduce risk for cardiovascular disease and increase lifespan. Currently, pharmaceutical companies only have to conduct studies to prove that diabetes medications regulate blood sugar levels. According to the Journal, a "shift away from current research benchmarks, called surrogate endpoints, might change the entire framework of drug approval" because the "more rigorous" benchmarks would require long-term clinical trials.

The pharmaceutical industry has "expressed concern that stricter long-term clinical tests could deter companies from investing in new diabetes drugs," the Journal reports. "If you start putting a greater emphasis on doing (testing) premarket, you greatly increase the cost of clinical trials, which may lead companies to rethink" plans to develop new drugs, Alan Goldhammer, deputy vice president of the Pharmaceutical Research and Manufacturers of America, said.

However, Loss said that pharmaceutical companies likely will not decrease their efforts to develop new medications for the profitable diabetes treatment market.

American Diabetes Association Vice President Sue Kirkman in a statement said, "We don't want it to become nearly impossible to bring effective new drugs to market, which requiring long-term pre-marketing (cardiovascular) studies might do" (Favole/Mundy, Wall Street Journal, 6/28).

Opinion Piece

The pharmaceutical industry is a "popular villain these days, thanks ... to the premise that drug companies are concerned more with profits than safety" and the "current mythology" that "most drug innovation comes from publicly funded research," Benjamin Zycher, senior fellow at the Manhattan Institute, writes in a Journal opinion piece.

Zycher cites the results of a study he conducted with two Tufts University researchers on the "development histories of 35 drugs and drug classes identified in the scholarly literature as important or that were among the most prescribed in 2007." According to Zycher, the study found that privately funded research was "responsible for central advances in basic sciences" in seven cases; in applied sciences for 34; and "in the development of drugs yielding improved clinical applications and/or manufacturing protocols for 28."

He writes, "All or almost all of the drugs and drug classes would not have been developed -- or their development would have been delayed significantly -- in the absence of the scientific or technical contributions of pharmaceutical firms," adding, "NIH and private sector research efforts are thus complementary." However, Zycher writes that "some current policy proposals ... would diminish private investment" and would "erode, perhaps sharply, the economic benefits of NIH research efforts as well." He concludes, "That is something that the critics of Big Pharma might want to consider" (Zycher, Wall Street Journal, 6/28).