Feb 11, 2020 - Health

FDA defends its drug approval process after controversial reviews

FDA headquarters. Photo: Al Drago/CQ Roll Call

Many experts have questioned the FDA's drug approval standards over the past few years, as several controversial drugs have gotten the green light despite less rigorous testing.

What they're saying: Peter Stein, the head of the FDA's office that analyzes new drugs, sat down with Zachary Brennan of Regulatory Affairs Professionals Society and said the only thing that's changed with the FDA's approval process is a shift in the types of drugs the agency is reviewing.

  • "If you look in the last couple years, we still see some drugs for chronic diseases, but even there, it tends to be subgroups and populations that were undertreated with drugs previously available, and what we're seeing is a dramatic increase in drugs for rare diseases," he said.

The bottom line: There's no doubt biotech startups and drug companies have invested more time and money in treatments that go after cancers or conditions that treat a very small subset of people. Those kinds of medicines usually command the highest prices.

  • And the FDA is saying those types of drugs have more leeway in the approval process, even if they only have one trial or don’t have randomized test groups, because "patients and physicians are willing to accept a bit more uncertainty."

Go deeper: FDA allows states to test for coronavirus for faster results

Go deeper

Scoop: Coronavirus threatens shortages of about 150 drugs

A medical worker in Beijing. Photo: Greg Baker/AFP via Getty Images

About 150 prescription drugs — including antibiotics, generics and some branded drugs without alternatives — are at risk of shortage if the coronavirus outbreak in China worsens, according to two sources familiar with a list of at-risk drugs compiled by the Food and Drug Administration.

Why it matters: China is a huge supplier of the ingredients used to make drugs that are sold in the U.S. If the virus decreases China's production capability, Americans who rely on the drugs made from these ingredients could be in trouble.

Go deeperArrowFeb 23, 2020 - Health

Coronavirus stress tests drug industry's dependence on China

A Hong Kong commuter wears a face mask. Photo: Miguel Candela/SOPA Images/LightRocket via Getty Images

It's unclear whether the rapid spread of the novel coronavirus will actually result in prescription drug shortages, but it has undoubtedly highlighted the potential vulnerabilities of having the supply chain for American drugs so dependent on China.

Driving the news: About 150 prescription drugs — including antibiotics, generics and some branded drugs without alternatives — are at risk of shortage if the coronavirus outbreak in China worsens, per two sources familiar with a list of at-risk drugs compiled by the Food and Drug Administration.

Go deeperArrowFeb 24, 2020 - Health

China's coronavirus outbreak prompts congressional scrutiny of health supply chain

Management personnel checks the production of medicine in a workshop of Youcare Pharmaceutical Group Co. in Beijing. Photo: Zhang Yuwei/Xinhua via Getty Images

The spotlight that the coronavirus has shone on our reliance on China for American drugs and medical devices has already prompted lawmakers to act.

Driving the news: Sens. Marco Rubio (R-Fla.) and Josh Hawley (R-Mo.) both plan to introduce bills aimed at safeguarding the supply chain.

Go deeperArrowFeb 27, 2020 - Health