FDA creates new committee to release early advisories on drug side effects
WASHINGTON The Food and Drug Administration has proclaimed that it will now release more warnings and advisories of side affects for many of the drugs on the market.
The decision stemmed from a confession that the FDA has been more focused on reviewing drugs before getting them on the market, and put less emphasis on monitoring drugs that are currently on the market. According to the Wall Street Journal, this was due to their lack of funds, which has changed recently, based on last year’s legislation which gave the FDA additional money and authority.
The officials of the FDA also stress that they will place emphasis on what they call “early communications,” which will be monitored by their new risk-communication advisory committee. Andrew Von Eschenbach, the FDA commissioner, stated, “I feel strongly it’s important for us to communicate early, but in communicating early we are acting with a much smaller degree of certainty. We are trying to get people to understand that we haven’t said there’s a problem, only that we are concerned there’s a problem.”
According to the Journal, the committee is comprised of outside academic and industry experts, which will aid in communicating risks and benefits for drugs, medical devices and certain foods.
This year, the FDA has already issued four public-health advisories, which warn consumers about certain health problems tied to drugs, compared with 11 advisories for all of 2007.
Combo vaccine for kids linked to fever and seizures
ATLANTA A study by the Centers for Disease Control and Prevention has shown that children suffered higher rates of fever-related convulsions when they got a Merck combination vaccine instead of two separate shots, according to published reports.
Prior to the findings, the CDC’s Advisory Committee on Immunization Practices had stated a distinct preference for the ProQuad vaccine, which protects against measles, mumps and rubella as well as chickenpox. The committee’s argument was that it would be better to give children the fewest injections possible.
Now, however, the committee has withdrawn its preference for ProQuad, choosing not to exhibit any preference at all. “Safety, shortages, delivery issues—lots of reasons not to state such a strong preference,” said a committee member. ProQuad costs $124 per dose, about the same as the two other shots combined.
In the study of children ages 12 months through 23 months, the rate of seizures was twice as high in toddlers who got ProQuad, compared with those who got one shot for chickenpox and one for the three other diseases. Neither the convulsions, nor the fevers that engendered them resulted in any child deaths. Merck has conducted its own study with similar results: 1 occurrence in approximately 2,000 children.
Procter & Gamble wins patent suit for Actonel
CINCINNATI The United States District Court of Delaware today ruled in favor of the Procter & Gamble Company in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals. The positive ruling protects P&G’s rights in the U.S. to exclusively market the osteoporosis therapy Actonel (risedronate sodium tablets).
P&G filed a patent infringement lawsuit in August against Teva to enforce P&G’s U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention.
The court ruled today in favor of the patent. “We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule,” said Tom Finn, P&G president of global health care. “We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures.”