Market Is Based Upon the Thesis

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The FDA will need to draw a line in the sand -- the goal of clinical trials isn't to save money, it's to test a drug's effectiveness.

Janet Rehnquist recommended that the FDA "exert leadership" on this issue. The complexities of globalized clinical trials do not lend themselves to half-hearted regulatory efforts. The problem with taking a more active role is that the FDA begins to become the regulator of regulators, which casts a wider net on its responsibilities than was ever intended. There is cause to want the FDA to consider the practical concerns, much less the ethical ones, in scaling back the reliance on non-U.S. clinical trials.

3. We agree that monitoring online marketing of drugs is going to be difficult. But since the Internet is the main source of information for a lot of people -- 91 million Americans a year look for health information online. With a pent-up demand among consumers and the industry stakeholders, it looks like the FDA is going to be pressed into action.

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Up until now, they have provided very little guidance on the matter.

Perhaps the most important aspect of this discussion is FDA marketing of third party online communications -- Facebook groups, blogs, and Twitter accounts. It would not be difficult for companies to circumvent whatever restrictions the FDA eventually decides with respect to online marketing by using third parties as information sources. The FDA has a long way to go in determining policy and it will be interesting to see what they come up with. Already drug companies are using third parties to gather information about potential customers -- they will surely extend their other tactics to the online sphere as well. How the FDA views the issue will go a long way to determining the future of drug marketing online.

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