‘It’s Already Too Fast’: Critics Warn That Speeding Up FDA Approval Process Dangerous For Patients
President Donald Trump's nominee to head the Food and Drug Administration has pushed the idea that the process is "cumbersome" and slow, but some challenge that it's actually the opposite.
Boston Globe:
Critics Worry Faster FDA Drug Reviews Could Compromise Safety
For biotechs, waiting for new drugs to be approved is not as hard as it used to be. Since late last year, federal regulators have acted months earlier than expected to OK a bumper crop of new drugs from Massachusetts companies. The speedy decisions are welcomed by businesses that have made massive investments in developing experimental medicines and are eager for them to start generating revenue. (Weisman, 4/10)
In other pharmaceutical news —
Kaiser Health News:
Drugmakers Help Turn Patients With Rare Diseases Into D.C. Lobbyists
Wearing a blue T-shirt and worn jeans, Marc Yale stood near the welcome pole at the annual Rare Disease Legislative Advocates conference handing out money. Envelopes in his left hand held $750 checks to help patients with a rare disease cover the cost of a whirlwind trip to the nation’s capital. The money was donated by the pharmaceutical industry. (Tribble, 4/10)
The Wall Street Journal:
China Emerges As Powerhouse For Biotech Drugs
A new cancer drug licensed by Eli Lilly was discovered by a six-year-old startup on the outskirts of Shanghai, and derived from the ovary cells of Chinese hamsters. Lilly now is planning to test it on Americans.Rival Merck & Co. aims to test a separate cancer drug in the U.S. this year, created by another startup near the border with Hong Kong. Those aren’t outliers. China, long the world’s supplier of cheap pharmaceutical ingredients and copycat pills, is emerging as a major producer of important new medicines: biotech drugs. (Rana, 4/10)
Bloomberg News:
Male Contraceptive In The Works In India, But Doesn't Look Likely To End Up On U.S. Market
Doctors are on the cusp of launching the first new male contraceptive in more than a century. But rather than a Big Pharma lab, the breakthrough is emerging from a university start-up in the heart of rural India. Years of human trials on the injectable, sperm-zapping product are coming to an end, and researchers are preparing to submit it for regulatory approval. Results so far show it's safe, effective and easy to use-but gaining little traction with drugmakers. (Altstedter, 4/9)
