STAT

Opinion: Lost opportunities from FDA, NIH inaction when sponsors fail to report clinical trial results

Not enforcing the Food and Drug Administration Amendments Act puts Americans at greater risk of wasting money on useless medical products and being injured by unsafe ones.
Anthony Fauci (left), director of the National Institute of Allergy and Infectious Diseases, walks past President Trump after answering a question during a coronavirus task force briefing.

Americans are learning a thing or two about clinical trials as they watch the tense, televised push-pull between President Trump promoting a drug combination for Covid-19 based on skimpy, preliminary clinical trial data and Dr. Anthony Fauci promoting caution about the combination. Fortunately, the federal government provides a handy resource for navigating such disputes, ClinicalTrials.gov, where drug makers and other sponsors of clinical trials must report their results.

The Food and Drug Administration bases its decisions largely on the results of such clinical trials, which reveal how effective or safe

You’re reading a preview, subscribe to read more.

More from STAT

STAT2 min read
STAT+: Pharmalittle: We’re Reading About Lilly Buying A Plant, A Pfizer Antibiotic, And More
Eli Lilly agreed to acquire a manufacturing facility in Wisconsin from Nexus Pharmaceuticals to produce injectable medicines amid shortages of Mounjaro and Zepbound.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About An OptumRx Contract, 340B Dispute Resolution, And More
Cardinal Health announced its pharmaceutical distribution contracts with UnitedHealth's OptumRx unit will not be renewed after they expire in June.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About CVS And Humira Biosimilars, Schumer’s Broken Insulin Promise, And More
New prescriptions for biosimilar versions of Humira, one of the best-selling drugs in the U.S., surged to 36% from just 5% during the first week of April.

Related Books & Audiobooks