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FDA Drug-Testing Process Allows Swifter Approval, But has Potential Risks

Oct 29, 2013

Of 20 new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008, eight had expedited reviews, reaching the market with significantly fewer patients studied than under standard approval process. And though all 20 drugs were approved with postmarket study provisions, a newly published article reports that 50 of 85 of these study commitments remained unfulfilled as of January 2013.

Thomas J. Moore, from the Institute for Safe Medication Practices, in Alexandria, Virginia, and Dr. Curt D. Furberg, from Wake Forest School of Medicine, Winston-Salem, North Carolina, studied 2008 FDA new approvals using agency documents, drug information databases, prescribing information, and other data sources, reports. Their study, published online in JAMA Internal Medicine, found that the drugs approved under the accelerated approval program received approval after a median of 5.1 years (range, 1.6 - 10.6 years) after efficacy testing in a median of 104 patients (range, 23 - 599 patients) compared with 7.5 years (range, 4.7 - 19.4 years) for drugs approved under the standard review process with a median of 580 patients (range, 75 - 1207 patients) for standard-review drugs.

The 20 drugs approved in 2008 were split evenly between inpatient and outpatient use, with seven of them approved with orphan drug status for rare diseases, including six of the drugs that received expedited review. All 20 drugs were still on the market as of January 2013, but drug sponsors had completed just 26 of 85 (31%) postmarketing studies and submitted data for FDA review for another 8 (9%). In other words, drug sponsors had not yet met promises for 50 of the 85 postmarketing studies required by the FDA in granting approvals. According to Medscape, the unfulfilled study commitments applied to both drugs that received accelerated approval (18/48 [38%]) and those that received standard approval (23/37 [48%]).

The authors note that new-drug testing has shifted from most testing occurring prior to approval to expedited approval where a drug enters the market after smaller, narrower trials, with more extensive testing to be conducted after approval. “[T]he shift has made it more difficult to balance the benefits and risks of new drugs," they write. Prof. Daniel Carpenter, from the Radcliffe Institute for Advanced Study, Harvard University, says weakening FDA testing requirements may weaken trust in the efficacy and safety of prescription drugs. “There is scarcely a feature of the American health care system,” he writes, “that does not depend on evidence-based trust in prescription drugs, ratified and enforced by the FDA,” according to Medscape.

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