Approvals of New Medications To Increase by 2010
FDA approvals of new medications have decreased in recent years, but likely will by 2010 increase as pharmaceutical and biotechnology companies seek approval for about 2,000 compounds currently in early stage clinical trials, according to a study released on Wednesday by the Tufts Center for the Study of Drug Development, the Newark Star-Ledger reports.
According to the Star-Ledger, FDA in 2006 approved only 17 new medications, "matching the lowest number of newly approved compounds since the peak of 53 approvals a decade ago." In addition, since the September 2004 market withdrawal of the COX-2 inhibitor Vioxx, FDA has approved 37 new medications, compared with an average of 28 annually in the years prior to the withdrawal.
The lack of new medications, which in recent years has prompted pharmaceutical companies to spend $40 billion annually on research and development, has led to flat earnings and sales for many companies and strong generic competition for older treatments.
Kenneth Kaitin, director of the Tufts center, said, "The industry is still suffering from very significant pipeline problems. The short-term future does not look tremendously promising for the pharma industry."
According to the Pharmaceutical Research and Manufacturers of America, pharmaceutical companies have in development 646 compounds for cancer, 146 for heart disease and stroke, 77 for HIV/AIDS and 56 for diabetes.
Alan Goldhammer, a deputy vice president for PhRMA, said, "There would be a much greater concern if there were a few number of compounds going into trials."
However, Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "The number of real innovations for diseases that never had a treatment before or drugs that are really better, there is just not much there. There just are not a lot of innovations lately" (Jordan, Newark Star-Ledger, 1/4).