The FDA should Not Mandate Comparative-Effectiveness Trials (Health Policy Outlook‪)‬

Next year, Congress will reauthorize legislation that helps fund the FDA drug-review program. The PDUFA requires drug companies to pay user fees to help defray some of the FDA's cost of reviewing applications. Consumer groups are making a hard push in Washington to use this fifth iteration of the PDUFA to add new requirements to the drug approval process. In particular, they want Congress to mandate that drug companies undertake "comparative effectiveness" studies prior to the approval of a new drug. These comparator trials would involve drug companies running clinical trials, prior to FDA approval, that pit their new medicines against current drugs. The ostensible goal is to require sponsors to prove that their new drug is better than a currently used medicine. Proponents argue that mandatory comparator trials would yield information that can improve prescribing decisions by steering patients to the most cost-effective treatment. They say such a scheme would lower health care costs by identifying when newer, and presumably more expensive, medicines are little better than cheaper, generic alternatives.