Science and Politics at the FDA - Pharmaceutical Executive

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Science and Politics at the FDA


Pharmaceutical Executive


PE. In the New York Review of Books, Marcia Angell allowed that your book is "exhaustively documented" and "ambitious," but she was critical of you for neglecting what she perceives as the central problem at the FDA: "How to ensure that CDER, free of industry influence, protects the public from unsafe, useless drugs." Why did you decide not to identify "problems" and recommend "solutions" after doing such a deep dive into the FDA?

DC: I'm not against making judgments. I agree with several of her suggestions, such as a fuller clinical trial database and faster generic approvals. But I believe in the value of an analysis that tries to understand the FDA for what it is, rather than what it should be.

PE: It is generally said that the FDA's priorities swing on a pendulum, between approving more drugs as fast as possible, and rejecting more drugs due to safety fears. Do you think that the "pendulum" metaphor is accurate?

DC: Pendulum metaphors should always be regarded with caution. The binary tradeoff between safety and access is far overplayed in our discussions about pharmaceutical policy. The transformative issues lie not in "safety versus innovation," but in providing good information that gives confidence to patients, physicians, health providers, and others who believe that the drug supply is characterized by safety and efficacy. My hypothesis is that the FDA's testing requirements establish not only a safer but also a more trustworthy marketplace.

PE: We seem to be entering an era where confidence in drug safety/efficacy evidence development and assessment is under assault due to a combination of factors, including the growing public accessibility of data, which leads to much expert "second guessing" of the decisions of advisory committees; the development of more sophisticated tools to analyze ever larger sets of data; and the effort by drug companies to be more transparent, which paradoxically has exposed corruption in their own disclosure processes. How can the FDA preserve its critical role as a gatekeeper if its authority to make even the most informed assessment of the data is increasingly undermined?

DC: You're right that the FDA and drug companies no longer have an oligopoly on possession of the data about drugs and those who test and market them. In terms of the FDA as gatekeeper, I suspect you will see more of what we saw in the Avandia decision, namely the FDA acknowledging that there are different hypotheses and arguments about the drug in question, and offering a rationale for its decisions. We live in a data-rich world where everyone is going to get second-guessed. But we still need a regulator to make final decisions according to public health criteria.

And as more second-guessing is done, I suspect you will see greater skepticism about the second-guesses themselves. The role of meta-analyses, epidemiologic studies, and even certain forms of randomized clinical trials is coming in for greater criticism. The FDA has issued its own guidance about meta-analyses, which suggests more doubt about their value. The agency is also trying to invest heavily in pharmacoepidemiology and statistics so that it can be a pivotal player in the public and scientific debates.

PE: How do you think the increasing globalization of the pharma market will impact the ability of the FDA to do its job?

DC: Globalization can weaken the FDA but also strengthen it. As other nations' drug markets grow larger, the pivotal nature of the FDA's gate-keeping power will decline, as it becomes less and less vital to get into the US market for drug companies to make a profit.

Another globalization effect is the growth of other nations' regulatory capacities; for safety's sake alone, we might welcome this. Americans' drug safety will increasingly depend upon the ability of regulators in India, China, and other countries to police the good manufacturing practices and quality of drugs produced there. The FDA knows this and is aggressively trying to help boost capacities and proselytize its models and practices overseas.

That said, the FDA model has been copied worldwide. As regulators in other countries begin to develop independent governmental capacities, they are seeking direct assistance from the FDA and more quietly copying (sometimes resisting) the FDA's decisions, structures, and processes.


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