Word: fda
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...lobbying is about to reach critical mass with states and cities squeezed by runaway health-care expenditures in general and the unchecked increase in drug prices in particular. Both have grown irritated with Congress's failure to consider pricing alternatives and have become especially annoyed lately with the FDA's threats to initiate legal actions against any government that seeks to enter into buying arrangements with the Canadians to slash their prescription drugs costs for employees, prisoners and Medicaid recipients. The latter group represents a significant financial burden for the states. Although the feds kick in some Medicaid money, overall...
...part, the FDA maintains that all these facilities are perfectly safe, that they have undergone inspections and that their manufacturing processes have been certified as meeting the agency's standards. But while the FDA does indeed inspect plants before opening, after that the oversight trails off. "The FDA has limited resources," an industry consultant told TIME. "The foreign drug-inspection program I don't think is very strong." Yet the industry is building more facilities abroad--both research and manufacturing complexes--placing an ever greater burden on an already overextended FDA staff...
...saving millions. Some two dozen other cities and states have begun efforts to link up with Canadian suppliers. "Cash-strapped state and local governments are looking for relief in a logical place," says Representative Jo Ann Emerson, a Missouri Republican. Further fueling the states' animosity toward the feds, the FDA has threatened legal action against state and local governments that pursue the Canadian option, thereby increasing the likelihood of another congressional showdown...
While it may provide some short-term relief, buying drugs in Canada is indeed a roundabout way for the U.S. to address the high cost. And selling drugs over the Internet, with the FDA's refusal to even consider a regulatory framework, isn't the answer either. No one disputes that while there are many legitimate online pharmacies, the Internet at the moment also has its share of charlatans and hucksters offering dubious and possibly dangerous products. When TIME asked a PhRMA spokesman why the industry simply did not designate one or more Internet pharmacies as approved sites, he replied...
...what's the FDA's position? Says Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research: "There's no structure set up for regulating a pharmacy...