BY ANDREW SIDDONS AND SANDHYA RAMAN, CQ ROLL CALL
A highly anticipated markup of a must-pass Food and Drug Administration bill was postponed Wednesday because of partisan sparring over the firing of FBI Director James B. Comey. The delay comes after the Senate Finance Committee last week indefinitely postponed a hearing on the Children’s Health Insurance Program because of the toxic politics of the Republican health care bill. The cancellations raise questions about whether a deluge of drama consuming the Capitol could push lower-profile but important health care legislation off the rails.
Both bills — which congressional leaders hoped to pass without major controversies — need to be addressed well before their Sept. 30 deadlines so the FDA employees and children’s health providers who rely on funding affected by the bills can keep working.
The Senate Health, Education, Labor and Pensions Committee markup of the FDA user fee bill was postponed because Democrats were meeting to discuss strategy after Comey’s dramatic dismissal, not because of the substance of the bill itself.
More broadly, the partisan bickering could also delay any progress on changes to the 2010 health care law, which has bitterly divided lawmakers despite some agreement that fixes are necessary to keep insurers in the individual insurance market.
“Premiums are being quoted, and they are driving up, so it’s going to continue to demand to be addressed, just because under current law, things are going terribly,” Louisiana Republican Sen. Bill Cassidy said.
At the moment, the children’s health insurance renewal seems more likely than the user fee bill to fall victim to partisan fallout by either being used as a bargaining tool in broader health care discussions or simply getting a one-year extension so Congress can deal with it later. Finance Committee spokespersons from each party said lawmakers did not want partisan politics and issues carried over from the acrimonious House debate to dominate the discussion at its CHIP hearing, but it is unclear when the bipartisan discussions would resume.
“In order to ensure the hearing will not be overshadowed by recent actions in the House on health care legislation, the committee will postpone the hearing until a later date,” Finance Committee GOP spokeswoman Amelia Breinig said last week.
“The House bill before the Senate seriously threatens the health care of millions of children. Senate Democrats look forward to having a bipartisan discussion about CHIP and ensuring the health care of all children is protected,” said Taylor Harvey, a spokesman for Sen. Ron Wyden of Oregon, the committee’s top Democrat.
Wyden told reporters Wednesday that the committee would next focus on Medicare policies related to patients with chronic illnesses. The panel is scheduled to hold a hearing on that subject on Tuesday.
Children’s groups are seeking urgency for resuming the CHIP discussion and are recommending extensions ranging from two to five or more years. The current worry among many industry groups is that states will not have enough time to make decisions about their budgets, even if legislation passes before the Sept. 30 deadline.
All states would exhaust their federal funds by the end of fiscal 2018, with four states and the District of Columbia running into trouble by even December, according to the Medicaid and CHIP Payment and Access Commission. CHIP provides health coverage for more than 8 million children.
“A delay will have real implications on CHIP, even if it is eventually extended. There is also a history of near-misses where funding expired or there were shortfalls and states know this history, even if congressional staff do not,” said Bruce Lesley, president of First Focus, a group that prioritizes children’s issues.
Drug and device debate
Lawmakers working on the FDA bill have tried to keep it as bipartisan and as free of controversy as possible. The bill would renew the FDA’s authority to collect fees from the drug and medical device industries. The fees pay the salaries of FDA employees who review applications, and if a bill isn’t passed by the end of July, the FDA will start issuing layoff notices to the employees, in case funding lapses. Even if the bill is done before September, it may be too late to prevent a brain drain of FDA scientists and statisticians who are highly sought after by the private sector.
The pharmaceutical industry and patient groups largely support the FDA bill and at this point are not panicked by the delay.
“This is one area where we really have seen strong bipartisan support from the get-go,” said Eric Gascho, vice president of policy and government affairs for the National Health Council, a coalition of patient groups sponsored by many pharmaceutical companies. However, he added: “With any piece of legislation, you always have to worry about some of the other politics coming into it.”
Despite the optimism, the health council, the National Organization for Rare Diseases and more than 100 other patient groups sent a letter to congressional leadership Friday warning against delay — or the passage of a short-term extension, an idea that, for the moment, no one in Congress seems to have seriously entertained.
If the user fee funding lapses, “the necessary review of innovative therapies would be substantially impaired, if not halted all together. Further delay, such as a one year extension of the current agreement, will impact FDA’s ability to carry out its vital mission,” the groups said.
Congress, the FDA and the regulated industries have been working on the user fee renewal for more than a year. With markups in both chambers pending and floor action expected in June, most observers think Congress is on track to get it done on time. The health committee’s leaders and rank-and-file members seem to think it will get done despite health law politics or the Comey affair.
“We can walk and chew gum, and do separate things. We’ve been involved in various partisan things for a while,” said Sen. Sheldon Whitehouse, D-R.I., a member of the Senate’s health committee. But, he added: “I don’t want to understate the importance of what the hell happened with the Comey firing.”