Unbiased Analysis of Today's Healthcare Issues
A paper by DiMasi et al. (2003) found that the cost of drug development was $802 million. This is a highly contentious number. Drug companies have used this number to lobby regulators to loosen the FDA approval process. The data used in the study, however, was confidential and could not be replicated by other authors.…
GoozNews reports that “the Senate Judiciary Committee…passed legislation prohibiting brand name drug manufacturers from paying off generic manufacturers in patent disputes. They get the money in exchange for not bringing the cheaper drug to market.” Is this a wise move for Congress? The main question one should ask is why brand name manufacturers pay off generic…
Marketplace reports that the FDA has blocked sales from one of India’s largest drug producers, Ranbaxy Pharmaceuticals. “It prevented sales of Ranbaxy’s generic versions of the antibiotic Cipro and the cholesterol pill Zocor.” This begs the question: should the FDA put office in foreign countries? On the one hand, it is important to ensure that imported…
Currently the FDA requires that drug companies conduct 3 phases in order to secure the approval of a pharmaceutical. These are: Phase I. These are smaller (20-80 participants), clinical trials which determine a drug’s safety and pharmacologic properties among healthy volunteers. Phase II. This phase tests a drug’s efficacy and optimal dosage. Typically 100-300 individuals…
The Food and Drug Administration is one of the most important government agencies. The FDA has an interesting history and below I will review some important dates. 1938 Federal Food, Drug and Cosmetic Act. This law was enacted after the drug Elixer Sulfanilamide killed over 100 people. Firms were required to submit new drugs to…