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Making Drugs Safe and Available without the FDA
Problems of Proposed Reforms
"Proposed reforms represent an enormous emprovement over the status quo."
Most of the proposed reforms represent an enormous improvement over the
status quo. However, they either create problems of their own or do not
adequately address FDA failings. Also, bills change significantly as they
move through the Congress from committee to floor to conference committee.
Often, to win passage, fundamental reforms are deleted. No matter how good
a proposal looks, the probability that it would pass Congress and become
law in its original form is low.
Increasing the Use of Independent Review Boards.
Greater reliance
on independent councils comprising researchers and possibly industry personnel
to review and approve drug applications would likely have one of two effects.
At one extreme, reliance on independent review boards might give industry
too much influence over the drug approval process. Researchers and manufacturers
deserve a place at the table, but if the FDA is forced to accept the advice
of industry-staffed review boards, its independence is sacrificed.
At the other extreme, the FDA might ignore researchers and manufacturers
even when they sit on the independent review councils. But if the FDA is
not required to respond to the industry, there is no reform at all. The
FDA would still be able to engage in the delaying behavior Sen. Barbara
Mikulski (D-MD) spoke of when she said, "There is enormous frustration
about ... enforcement over approval, about nit-picking over a label as compared
to really focusing on moving to the marketplace."36
Then there is the middle road for the FDA, the road already taken. This
balanced path between industry and FDA monopoly is full of difficulties
as well. The researchers and medical professionals who staff the FDA's review
boards have little incentive to devote the necessary time and energy. They
have other full-time occupations, yet they must know about medical therapies
as well as clinical testing theories and practices. And they are supposed
to have no conflicts of interest.
The reality is that review panel members may have little if any knowledge
of the science behind a new product. And the FDA can and does exercise waivers
for panel members who have financial or other conflicts of interest.37
Independent review boards have their own built-in delays. Review boards
are required to operate separately from any manufacturer. No cooperation
between them during design and production of a product is permitted. This
forces the manufacturer to complete all of its work before submitting it
to the body that must then review all of the data.
Increasing the Use of Third-Party Certification. Drug companies could bypass the FDA if they could contract with a third party to certify their test results, then market their drugs. Increasing the number of therapies that can be independently certified could save American lives. This reform would move the U.S. closer to Europe's system of private, often competing, certification bodies. However, the congressional proposals would still allow the FDA to block or delay the marketing of drugs.
And the third-party certification system has the same sort of delay built into it as does the independent review board system. The manufacturer must incur all the time and expense of development. Then it must seek - and perhaps fail to receive - the recommendation of the third party.
Another key defect in the House and Senate plans is the proposed accreditation process for the third-party reviewers. The Senate plan leaves the process up to the FDA commissioner. The House plans spells out accreditation requirements. Authority to set the requirements is a powerful tool, determining the nature, characteristics and behavior of the third-party reviewers. The House plans would invite outside influence, since adjusting or adding to the requirements would be a congressional and therefore a political decision.
Using Performance Standards. Currently, the FDA has no definite standards of performance for safety or effectiveness that a drug can meet to ensure approval. Written standards, harmonized with those of the rest of the world, would be an improvement over current policy. However, government-mandated or approved standards would have a subtle yet profound influence on drug company research. Research would focus on creating drugs that would meet the standards, not simply save lives and ease pain.
Further, FDA-imposed standards, set by the commissioner in consultation with interested parties, would reflect the concerns of the special interests. Protecting the standards from this pressure is too much to ask of any provision limiting conflicts of interest. Harmonizing U.S. standards to international standards might do no more than allow foreign special interests to influence U.S. drug approval procedures. Finally, FDA-imposed standards would inevitably become politicized. While its proponents might argue that the agency is insulated from special interests, the FDA gets its budget and mandate from Congress, which resists few political pressures.