FDA’s Reagan-Udall Foundation rushes to begin in wake of criticism
WASHINGTON The Reagan-Udall Foundation, the new drug research center from the Food and Drug Administration is being moved with unprecedented speed to begin its job of improving the development of drugs and medical devices, according to the Associated Press.
The problem with the foundation is that it will be paid for by the companies it regulates and has already seen criticism for this relationship because; critics argue that the FDA has become too involved with drug companies. Sen. Edward M. Kennedy, D-Mass., a co-sponsor of the bill says the bill requires “effective safeguards to ensure that the foundation is independent of both the FDA and its donors, whether those donors are from industry or are charitable organizations.”
The goal of the foundation is to decrease the spending on drug development, while increasing the number of new drugs that reach the market each year. But again, the criticism is that drugs could be developed more cheaply, but that does not mean they will be safer and less expensive for consumers.
Wyeth hit with $134.5 million in Nevada lawsuit
RENO, Nev. Wyeth has been ordered by a Washoe county court to pay more than $43 million each to three northern Nevada women who claimed that the company’s hormone replacement drugs, Prempro and Premarin caused their breast cancer, according to the Reno Gazette-Journal.
The jury said the drugs were defective and found the company negligent for producing, manufacturing and selling them. The jurors awarded $7.5 million to each woman in past damages and $36 million-$40 million in future damages.
The jurors still have to decide whether the company is liable for punitive damages. Wyeth is also fighting about 5,300 similar lawsuits involving 7,800 women in state and federal courts across the country.
Teva sues Apotex over Coreg infringement
TRENTON, N.J. Teva has sued Apotex to prevent it from selling a generic version of the heart medication Coreg, according to Bloomberg.
The two companies, as well as other generic drug makers, received approval from the Food and Drug Administration to sell a generic version on Sept. 5. Teva says it owns four patents that cover various forms and processes to make the generic, carvedilol. The company also said that Apotex might have to buy the compound made using the patented process in order to sell the generic.
The lawsuit was filed yesterday in a federal court in New Jersey. Coreg had sales of $853.8 million in the first six months of 2007.