New Drugs

A new study by researchers at Virginia Commonwealth University argues that more should be spent on improving care quality and less on developing new drugs. VCU professor Dr. Stephen Woolf writes in the Annals of Family Medicine that more lives would be saved if the money went directly to programs that work to improve care quality processes. "For every dollar Congress gives the National Institutes of Health to develop blockbuster treatments, it spends only one penny to ensure that …

After a two year search, a new head of the FDA's Office of Drug Safety has been named. Dr. Gerald Dal Pan, an official with the Center of Drug Evaluation and Research who has been with the agency for five years, was appointed to the post Wednesday. The Office of Drug Safety is among the most closely watched units in the agency given recent concerns about FDA oversight of new drugs. Article

A news study conducted by researchers at Tufts argues that quicker FDA approval times for new drugs has had little or no impact on drug safety. That argument runs counter to critics who in part blame looser rules for the jump in safety problems in recent years. Researchers at the Tufts Center for the Study of Drug Development found that in the 1980s, 3.2 percent of drugs approved for sale in the US market were recalled. The authors note that since the year 2000, that number has fallen to …

A landmark NIH study of schizophrenia drugs is out this week, with some surprising findings on several medicines commonly used to treat mental illness. The government-backed research found that the older generic anti-psychotic perphenazine performs as well as newer (and far more expensive) brand name drugs like Johnson & Johnson's Risperdal, AstraZeneca PLC's Seroquel and Pfizer Inc.'s Geodon. Eli Lilly and Co.'s Zyprexa did better than other new drugs, but fears about the medicine's …

Wall Street reacted favorably to the appointment of Dr. Scott Gottlieb to the FDA's No. 2 job this week. Critics, however, are questioning Gottlieb's ties to investors and his stance on fast-track approval for new drugs. The Seattle Times, which recently ran a series exposing questionable business relationships between prominent medical researchers and Wall Street, writes that the appointment may "send exactly the wrong message." Gottlieb denies any potential conflict of …

The Food and Drug Administration will review three potential blockbuster drugs in early September. Observers say the agency may raise the bar after the high profile drug safety stories of the last year. The three new drugs include Pfizer's inhaled insulin Exubera and two drugs developed by Bristol-Myers Squibb: the new rheumatoid arthritis treatment Orencia, and Pargluva, which targets adult-onset diabetes.

- see this story in The Wall Street Journal (sub. req.)

Many legal observers say testimony in the first half of the Ernst v. Merck trial has favored the plaintiff, a development which could be an ominous sign for the drug maker. The New York Times reports that after a bumpy start, plaintiff attorney W. Mark Lanier seems to be making progress in winning over the jury in the case. The evidence presented in the case appears to have bolstered Lanier's argument that Vioxx was responsible for the death of Robert Ernst. The occasionally …

As expected, the Pharmaceutical Research and Manufacturers Association (PhRMA) released a new set of guidelines this morning intended to address criticism that the drug industry's ads sometimes mislead consumers. If the self-enforced rules are obeyed, the result could be a major change in the drug advertising campaigns Americans see on television. Drug companies will be required to submit spots to the FDA for approval. The new policy also outlaws the brief 15-second spots known as …

The drug industry released new guidelines which respond to recent criticism of its advertising practices. The proposal would impose a waiting period before companies can advertise new drugs, an idea modeled after the 12-month self-imposed moratorium on new ads recently announced by Bristol Meyers Squibb. The industry guidelines do not specify how long companies must wait before airing ads, however. Also included are new restrictions on content and the hours at which some ads can be shown. …

GlaxoSmithKline announced plans to launch five new vaccines over the next five years. All told, the new drugs have a projected market value of $11 billion to $18 billion. The five include Cervarix, designed to protect against cervical cancer; Rotarix, which fights rotavirus gastroenteritis; and Streptorix, for pneumococcal disease. The company is also touting an improved flu vaccine and a new combination designed to combat meningitis.

- see this story from the Philadelphia Business Journal