Members of the U.S. Senate and House of Representatives met Thursday to hash out a budget bill for a number of agencies, including the NIH, but an amendment dealing with drug prices in direct-to-consumer (DTC) ads failed to draw enough support to be reinserted into the appropriations bill. The matter is ended for now, but the concept enjoys bipartisan support on Capitol Hill and the support of the Trump administration, which has opened a docket number for drug price transparency.
The conference committee examined two spending bills – two of the three so-called minibus bills on tap for fiscal 2019 spending – for both the Department of Health and Human Services (H.R. 6157) and the funding bill for the Department of Agriculture and the FDA (H.R. 6147). H.R. 6157 will have to be voted on one more time in both chambers, votes that are expected to take place prior to the end of the soon-to-expire fiscal year.
No action on FDA spending bill
Conversely, while H.R. 6157 passed without too much difficulty, conferees broke for the afternoon without a decision on the FDA-related bill, H.R. 6147. That bill ran into headwinds during afternoon debate over ballot security considerations and the question of the proper federal government jurisdiction over cell-based meats. Consequently, the FDA and other agencies covered by that legislation may end up in a continuing resolution that would fund those agencies through Dec. 7.
The Senate had passed a spending bill that covered NIH appropriations in August, which would have provided the agency with roughly $39 billion in the coming fiscal year. Sens. Dick Durbin (D-Il.) and Chuck Grassley (R-Iowa) prodded other senators during the hearing about the need for price transparency in DTC ads, although the notion came up short during discussions. Nonetheless, Durbin's bill was added to the Senate bill behind closed doors, a move that triggered immediate criticism from industry. (See BioWorld MedTech, Aug. 27, 2018.)
Several weeks earlier, the Senate passed a spending bill for the FDA and other agencies that would have funded the FDA with more than $5.4 billion. Roughly $1.72 billion of that sum would be directed toward the Center for Drug Evaluation and Research, while the Center for Devices and Radiological Health would take slightly less than $496 million. (See BioWorld MedTech, Aug. 2, 2018.)
The drug pricing proposal may not need a specific set-aside of funds, however, assuming the Department of Health and Human Services can avail itself of existing funding mechanisms. The Office of Management and Budget has an Aug. 21 entry with a regulation identifier number of 0938-AT87, which carries a docket number of CMS-4187-P, indicating that CMS is the requesting agency. However, a search of that docket number at the website for the Federal Register and at regulations.gov returned no hits on Sept. 13.
While several congressional leaders touted the resumption of normal order for federal appropriations, Durbin argued that Grassley's backing for the $1 million for DTC ad regulations proves that the proposal "is not a Democratic poison-pill rider." Durbin noted that the White House has backed the idea, adding, "I don't often quote Donald Trump's tweets," but noted the president has tweeted his support for the concept. Durbin also said that HHS Secretary Alex Azar is "really committed to this" as well.
As the vote came up for his amendment, Durbin said, "I made my speech, I don't need to make it again." Sen. Richard Shelby (R-Ala.) offered mild support, stating that "this might come about someday, but not today." Durbin received little support from his side of the aisle, as indicated by remarks by Sen. Pat Leahy (D-Vt.), who stated, "I have to join with Sen. Shelby. We have kept to our agreement" with the House of Representatives to omit the provision.
Durbin claimed that prescription drug costs are "the number one driver" of health care inflation, but withdrew the amendment before a vote could be conducted.