- The Senate on Wednesday overwhelmingly confirmed President Obama's nominee for FDA Commissioner, Dr. Robert Califf, by an 89-4 vote.
- The four senators voting against Califf were Kelly Ayotte (R-NH), Richard Blumenthal (D-CT), Joe Manchin (D-WV), Ed Markey (D-MA). Two senators, Bill Nelson (D-FL) and Rob Portman (R-OH), had previously voted against Califf in a procedural vote on Monday but changed their vote to support his confirmation on Wednesday.
- Califf enjoyed wide support in the Senate, but he did face notable opposition over his alleged ties to the pharmaceutical industry and concern over the FDA and Califf's role in the growing number of opioid overdose deaths in the U.S.
Califf will have a long list of important issues to address as FDA commissioner. Over the past year, high drug prices have galvanized criticism and anger against the pharmaceutical industry. While certain companies, like Valeant and Turing Pharmaceuticals, have borne the brunt of this, the industry as a whole has felt the effects.
The FDA is not involved in the pricing of drugs, but as commissioner, Califf will be a public face in the back-and-forth between public concerns about drug affordability with fostering continued R&D from pharma.
Furthermore, Califf will take over at a time when biosimilars have begun to enter the U.S. biologic market. Currently, companies are granted 12 years of data exclusivity for their branded biologic drugs. But the recently signed (but not ratified) Trans Pacific Partnership limits this to between five and eight years.
Lawmakers have voiced their concerns this will compromise U.S. pharma companies' ability to recoup investments in innovation. The FDA will play an important role in the development of this market and in the marketing of new biosimilar drugs.
The FDA has also worked to accelerate its turn-around on approving new drugs, as both industry and patients have pushed for new treatment options. This has raised some concerns among lawmakers, however. During his confirmation process, senators questioned Califf on how the FDA will balance patient safety while working to speed up drug approvals. This issue will be of particular relevance as more pharma companies eye orphan drug development.
Opioids and the FDA
Despite the lopsided voting on both days, his nomination was not without controversy.
On Monday, six senators had voted against Califf (Nelson and Portman switched to yes on Wednesday), with almost all of them citing their concern over the FDA's—and by extension, Califf's—role in the growing opioid crisis and his supposed close ties to the pharmaceutical industry.
According to the Centers for Disease Control and Prevention, the rate of drug overdose deaths in the U.S. has tripled since 2000. In 2014, the latest year with available data, 28,647 Americans died from opioid-related drug overdoses (including heroin).
Senator McConnell (R-KY) argued—and many senators agreed with him—that this crisis would be best addressed with the experienced Califf leading the FDA. As commissioner, Califf will have to demonstrate his commitment to tackling this issue. Many of the senators voting for him are eager to see further work done to combat opiate abuse.
The senators who voted against Califf have sharply criticized the FDA for how it has approached approving opioid painkillers. Earlier in the week, Senators Markey (D-MA) and Manchin (D-WV) held a powerful press conference urging the FDA to take the opioid crisis more seriously. While the FDA has announced a major overhaul to how it will handle opioid approvals, Markey and Manchin have argued this does not go far enough to address the issue.
Editor's note: This post has been updated to highlight challenges Robert Califf will face as FDA commissioner.