2005: The Year in Drugs
January 24, 2006
More pharmaceutical research dollars didn't mean more new drugs in 2005, according to a report in The New York Times.
Despite drug companies' record investments in research, the US Food and Drug Administration (FDA) approved only 20 new drugs in 2005-compared with 36 in 2004. This is the lowest number of new drug approvals in one year in the last decade, according to The New York Times.
In contrast, research-dollar spending reached a zenith in 2005, surpassing $38 billion, although major drug companies, including Johnson & Johnson, Pfizer and Eli Lilly, failed to win approval for drugs invented in their own research laboratories.
The dearth of FDA approvals comes at a time when scientific research is opening numerous windows on the mechanisms of disease progression, which should suggest new possibilities for treatment approaches. However, these discoveries have yet to translate into successful drug development and approval.
Drugs that were expected to receive approval last year included prominent new treatments such as Bristol-Myers Squibb and Merck's Pargluva, a diabetes drug, and Pfizer's Exubera, a form of inhaled insulin.
Why the Drug Drought?
Some analysts predict that current research investments will begin to pay off in the next few years, but the FDA and drug companies both acknowledge that changes are needed to streamline the drug-testing and -development process.
''Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end,'' said Dr Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, according to The New York Times.
However, as the FDA seeks to implement ways of improving the drug-approval process, Food and Drug Administration-and members of Congress-are demanding that drugs be tested even more extensively before the FDA approves them.
Some industry professionals have speculated that the FDA may be denying or delaying approval of acceptable new treatments because of the fallout from the ongoing Vioxx trials. Although manufacturer Merck withdrew Vioxx from the market in 2004, after a clinical trial showed it increase cardiac morbidity risks in patients who had taken in for 18 months or more, the FDA came under fire for not forcing the withdrawal sooner.
According to Dr Gottlieb, the FDA's attitude towards drug approvals has scarcely changed, if at all, and has had a fairly consistent approval rate for the past several years. He also notes that drug companies are submitting fewer applications, according to The New York Times.
Pharmaceutical stock prices have declined in part because of the reduced number of new drugs, according to industry analysts. Albert Rauch, a pharmaceutical industry analyst at A. Edwards & Sons, says that the FDA is not responsible for the decrease in new drug approvals in 2005, according to The New York Times.
''Some of the drugs that didn't make it through, they had issues,'' Mr Rauch reportedly said. ''If you come up with something that's unique and really has a unique advantage, the FDA's very receptive to that.'' He noted that the industry was most likely at a low point in the drug-development cycle, an arduous process that usually lasts at least 10 years, and that the research would pay off in the next few years, yielding a new crop of drug approvals.
Supporting Mr Rauch's theory is a December 2005 report from Merrill Lynch, which noted that the number of potential new drugs in Phase I and Phase II testing has almost doubled in the last ten years-from 1,010 in 1995 to 1,971 in 2004. However, the number of drugs in Phase III trials (the final phase) has been under 400.
The report also warned that advances in early-stage development may result in attrition of the number of drugs that eventually move into the later stages. ''Technological advances may have allowed companies to more easily create new therapies, thus boosting the number of compounds in early development,'' the report said, according to The New York Times. ''But the increasing complexity of the targeted disease could mean that it is hard to predict efficacy and safety.''
Source:
Drugs in '05: Much Promise, Little Payoff; Just 20 New Products Are
Approved, Despite Biotechnology's Hope, The New York
Times, January 11, 2006.
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