Word: fda
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However, perhaps the companies shouldn't freak out - yet. The DTC issue has not been floated as an early White House priority; it is unlikely to be dealt with until weeks or months after Obama names a nominee for FDA commissioner, an announcement that could come within days. Plus, some of DTC's most vocal critics in Congress aren't calling for an all-out advertising ban. For example, Democratic Representative Bart Stupak of Michigan, chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, wants a moratorium on DTC ads during a drug's first two years...
...Stupak one key point. Yes, he also supports a two-year DTC moratorium for new drugs. "Americans must face an inconvenient truth about drug safety," he says. "The truth is that we inevitably allow drugs on the market whose risks are not fully known." Waxman, however, insists that the FDA should have the discretion to make exceptions to the moratorium. This policy follows a recommendation that the Institute of Medicine offered in a 2006 report, "The Future of Drug Safety." "It doesn't have to be a full two years," Waxman says. "It's allowed to be limited to drugs...
...figures that if the pharmaceutical moratorium were in place last year, magazines as a group would have lost roughly $210 million, or 0.8% of the approximately $25 billion in total ad revenue it took in for the year. And that's using a worst-case scenario in which the FDA kept all new drugs off the ad market for two years. Similarly, television outlets would have lost some $423 million, or 0.7% of its $60 billion in total ad revenue for the year. (See who's who in Obama's White House...
...other programs at a time when his critics say the state could least afford it. The governor is alleged to have gone around the legislature by simply ordering departments to carry out his directives - including bringing in prescription drugs from Canada and purchasing a flu vaccine outside of FDA supervision...
...that process wasn't such an easy hurdle to overcome. Because no one has used embryonic stem cells or the cells derived from them in people before, the FDA was particularly cautious. The trial that it approved is what's known as a Phase 1. It will involve no more than a dozen patients and is not designed to test the effectiveness of the cells. Rather, it will simply monitor the safety of inserting them into people. The researchers will be looking for whether the cells cause tumors, trigger an immune response or start to migrate away from the spinal...