The idea is to help people so desperately ill that they can't afford to wait for a drug to clear the standard FDA approval process. The agency received permission in 2012 to give certain drugs, those deemed to provide a "breakthrough therapy" for serious illnesses, a speedier route to market. A CNN investigative looks at one such drug that received this designation— Nuplazid, which is made by Acadia Pharmaceuticals and designed to treat Parkinson's patients suffering from psychosis and hallucinations. An FDA panel gave the green light for Nuplazid to hit the market in June 2016, despite some panel members' worries that not enough data existed to demonstrate its effectiveness and safety. Still, family members rushed to buy it, and sales boomed to $125 million in 2017.
The drawback? Families, doctors, and other health care professionals have since reported more than 1,000 "adverse events," a category that covers everything from fatigue to falls to deaths. FDA data put the number of reported deaths among those taking the drug at 700, with Nuplazid the only drug listed as "suspect" in 500 of those deaths. Acadia says the numbers can be explained—those taking the drug are often in the most advanced stage of the disease, for one thing—and while the FDA is monitoring the issue, the agency hasn't seen enough evidence to take the drug off the market. Critics, however, are calling for a more thorough review. "This is exactly what I thought was going to happen," says the doctor who led the initial FDA review and voted against its approval. Read the full story.