Califf Defends FDA Role in Patent Listings

U.S. Representative Ro Khanna (D-CA) took FDA commissioner Robert Califf to task during a House Oversight Committee hearing 4/11 on the agency’s Orange Book and frivolous patents that are listed there to prevent cheaper generics from coming to market. The lawmaker said Americans are frustrated because they are having to pay thousands of dollars for cancer drugs or multiple sclerosis drugs, and brand drug makers are being allowed to game the system by listing frivolous patents.

Califf defended the agency’s role as being “ministerial,” but Khanna argued during questioning that the agency has more discretion than it admits. “Not really, we have to list them,” Califf answered. “What would happen if you didn't list them?” Khanna asked. “We’d get sued,” said Califf.

“Now you can say the blame is with the patent office,” Khana pressed him further, “but if those were not listed at the FDA you'd have generic alternatives… Is that not correct?”

Califf told the lawmaker that the issue he raised is a “point of emphasis between us and the patent office now to try to get rid of frivolous patents.” Deciding what is a frivolous patent is also a Federal Trade Commission decision and priority, he said, adding that he has personal opinions on the matter. “And just what are those?” Khanna asked. “There are too many efforts made to extend patents,” Califf responded.

Khanna asked further about what Congress can do to help eliminate frivolous patents, and Califf said it might be best to get a meeting together with FDA’s staff and the patent office’s personnel to see if a remedy can be reached.

Khanna next went after Califf on the consulting fees he could get after leaving office, asking if he would pledge not to accept them from industry once he leaves the agency. Califf noted that he already has pledged not to lobby the agency for two years. “Beyond that point, you know, we'll have to see,” he said.

This was not acceptable for Khanna, and he nudged Califf yet again. “So why not just make that commitment so that the American people have confidence that you won’t take money from big pharma?” the lawmaker asked, adding that Califf can make plenty of money at Google or somewhere else.

“I'm not looking to make money, I'm looking to contribute to the development of effective products,” Califf retorted. “I certainly have made a commitment for a period of time, but I can't speak for the rest of my life… I appreciate your opinion.”