Most Clicked FDLI SmartBrief Stories
1. Generic-drug makers say big drugmakers restrict access to samples
FDLI SmartBrief | May 23, 2012
The Senate and the Federal Trade Commission are examining generic-drug makers' assertions that some drugmakers prevent development of generic drugs by exploiting FDA-imposed restrictions on distribution. Generics makers need to test their versions against samples of branded drugs, but they say the drugmakers are refusing to sell to them. Washington Post, The (05/22)
2. Senate adds 10 amendments to user fee bill
FDLI SmartBrief | May 25, 2012
The Senate considered almost 20 amendments as part of Thursday's vote to reauthorize the prescription drug and medical device fees. Among the 10 measures approved were amendments that call for greater protection for whistle-blowers, a report on the FDA's small-business efforts and a review of the agency's communication plan with a focus on underrepresented populations. FDALawBlog.net (05/25)
3. Senate rejects drug reimportation, supplement registry
FDLI SmartBrief | May 29, 2012
The Senate rejected some amendments to the Prescription Drug User Fee Act reauthorization, including those to allow Americans to purchase drugs from Canada, revoke exclusive marketing rights for drugmakers found guilty of fraud and require dietary supplement makers to register with the FDA. The Senate also rejected an amendment to ban drug companies from making deals to delay market entry of generics. Hill, The (05/24) Hill, The (05/24)
4. Senate OKs FDA plan for review fees from drug and device firms
FDLI SmartBrief | May 25, 2012
The Senate voted to allow the FDA to collect on a $6.4 billion fee deal with companies including Eli Lilly and Co. and Medtronic to finance review of treatments and medical devices through 2017. The House might vote next week on the legislation, which could become law by Oct. 1. MedPage Today (free registration) (05/24) Bloomberg Businessweek (05/25)
5. Dietary supplement faces class action in Calif.
FDLI SmartBrief | May 23, 2012
A class action was filed in California over the dietary supplement Craze manufactured by Driven Sports. The lawsuit says that the product contains amphetamines, which a company official said was not true. NutraIngredients (05/21)
6. FDA panel doesn't endorse J&J and Bayer's Xarelto for ACS
FDLI SmartBrief | May 24, 2012
An FDA advisory panel voted against Johnson & Johnson and Bayer's anti-coagulant Xarelto for patients with acute coronary syndrome. The panel was concerned about bleeding risk and said missing data could distort results. A final ruling from the FDA is expected by the end of June. CNBC (05/23)
7. Senator's egg bill would require colony cages for hens
FDLI SmartBrief | May 29, 2012
Sen. Diane Feinstein, D-Calif., has proposed setting a nationwide standard for hen housing. Many major livestock groups oppose the bill, saying it could lead to federal limitations on other farm animal industries. The bill would require a shift from conventional cages to colony cages before 2030. Brownfield (05/25)
8. Shanghai Pharma reportedly being investigated for buyouts
FDLI SmartBrief | May 24, 2012
Shanghai Pharmaceuticals Holding is under investigation for its acquisition of Shanghai Asia Pioneer Pharmaceutical and Changzhou Kony Pharma after it listed last year on the Hong Kong stock exchange, a source said. Securities regulators in China and Hong Kong are conducting the inquiry. Bloomberg Businessweek (05/23) Elsevier Business Intelligence (05/23) Reuters (05/23)
9. Improve Your Mental Toughness in 2 Minutes
FDLI SmartBrief | May 29, 2012
OPEN Forum blogs (05/28)
10. Bill aims to better monitor drug wholesalers
FDLI SmartBrief | May 23, 2012
Rep. Elijah Cummings, D-Md., proposed the Gray Market Drug Reform and Transparency Act to strengthen supervision of drug wholesalers by banning them from buying drugs from pharmacies and compelling distributors to inform buyers about prices of scarce medications. "This bill closes down loopholes in the supply chain and ensures that consumers have more information about who is handling their drugs," Cummings said. Modern Healthcare (subscription required) (05/22)
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