The Hill
By Peter Sullivan - 09/20/16
http://thehill.com/policy/healthcare/296891-medical-cures-bill-pushed-back-to-lame-duck
Legislation to speed the approval of new medical cures will not move in Congress before lawmakers leave town for the election despite a last-minute push, lobbyists and aides said.
House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) is not planning to introduce a new version of his 21st Century Cures Act before the recess after all, the sources said. However, he is still hoping to get the legislation passed in the lame duck session after the election.
The legislation to speed the Food and Drug Administration’s approval of new drugs and to give an infusion of new funding for medical research is Upton’s signature bill. It passed the House last year on a broad bipartisan vote, but since then has been mired in the Senate amid months of negotiations over how to pay for the roughly $9 billion over five years in new research spending.
Upton, sensing that the clock is ticking, had pushed in recent weeks to introduce a new version of the legislation, with different spending offsets, in the House. He hoped to get it passed before the election, setting up the Senate to take it up after the general elections.
But Energy and Commerce Committee Republican staff members told research advocates at a meeting on Tuesday that the plan is now not to introduce a bill until after the recess. Instead, the committee majority is hoping to put out a joint statement with the panel’s Democrats before the recess pledging support for passing the bill in the lame-duck session.
“We don't have any comment on the meeting, but are hopeful we can get this done for patients soon,” a spokesperson for the committee majority said in a statement.
Lobbyists said there was simply too much work remaining for a deal to be reached in time to move the bill before the election and that election-year politics complicated the effort as well.
Upton is well-liked and has been pushing tirelessly for his signature bill, but it has faced strong headwinds. Finding a bipartisan agreement on billions of dollars in offsets has proven extremely difficult. Offsets used in the version of the bill that passed the House last year, which included selling oil from the Strategic Petroleum Reserve, were used up in other legislation later in the year.
In theory, though, the bill has backing from leaders in both parties. The measure could be a vehicle for funding Vice President Biden’s cancer “moonshot,” for example.
Another complication for the bill is that the pharmaceutical lobby opposes a possible addition to the measure that would help pay for it. That measure is called the CREATES Act and is aimed at increasing competition from generic drugs by fighting a delaying tactic where brand-name companies withhold samples of their products needed in the regulatory approval process for generic drugs.
Generic drug manufacturers, though, have warned that branded-drug companies have been seeking to water down the language through negotiations with lawmakers.
Sen. Bill Cassidy (R-La.), a member of the Senate Health Committee, which is taking the lead in that chamber, called the medical cures bill a “lame-duck priority” at an event hosted by The Hill on Tuesday.
Asked in an interview if he was confident the bill would pass in the lame-duck session, Cassidy laughed.
“Would I bet my house on it? No,” he said. “Would I bet your house on it? Of course.”
By Peter Sullivan - 09/20/16
http://thehill.com/policy/healthcare/296891-medical-cures-bill-pushed-back-to-lame-duck
Legislation to speed the approval of new medical cures will not move in Congress before lawmakers leave town for the election despite a last-minute push, lobbyists and aides said.
House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) is not planning to introduce a new version of his 21st Century Cures Act before the recess after all, the sources said. However, he is still hoping to get the legislation passed in the lame duck session after the election.
The legislation to speed the Food and Drug Administration’s approval of new drugs and to give an infusion of new funding for medical research is Upton’s signature bill. It passed the House last year on a broad bipartisan vote, but since then has been mired in the Senate amid months of negotiations over how to pay for the roughly $9 billion over five years in new research spending.
Upton, sensing that the clock is ticking, had pushed in recent weeks to introduce a new version of the legislation, with different spending offsets, in the House. He hoped to get it passed before the election, setting up the Senate to take it up after the general elections.
But Energy and Commerce Committee Republican staff members told research advocates at a meeting on Tuesday that the plan is now not to introduce a bill until after the recess. Instead, the committee majority is hoping to put out a joint statement with the panel’s Democrats before the recess pledging support for passing the bill in the lame-duck session.
“We don't have any comment on the meeting, but are hopeful we can get this done for patients soon,” a spokesperson for the committee majority said in a statement.
Lobbyists said there was simply too much work remaining for a deal to be reached in time to move the bill before the election and that election-year politics complicated the effort as well.
Upton is well-liked and has been pushing tirelessly for his signature bill, but it has faced strong headwinds. Finding a bipartisan agreement on billions of dollars in offsets has proven extremely difficult. Offsets used in the version of the bill that passed the House last year, which included selling oil from the Strategic Petroleum Reserve, were used up in other legislation later in the year.
In theory, though, the bill has backing from leaders in both parties. The measure could be a vehicle for funding Vice President Biden’s cancer “moonshot,” for example.
Another complication for the bill is that the pharmaceutical lobby opposes a possible addition to the measure that would help pay for it. That measure is called the CREATES Act and is aimed at increasing competition from generic drugs by fighting a delaying tactic where brand-name companies withhold samples of their products needed in the regulatory approval process for generic drugs.
Generic drug manufacturers, though, have warned that branded-drug companies have been seeking to water down the language through negotiations with lawmakers.
Sen. Bill Cassidy (R-La.), a member of the Senate Health Committee, which is taking the lead in that chamber, called the medical cures bill a “lame-duck priority” at an event hosted by The Hill on Tuesday.
Asked in an interview if he was confident the bill would pass in the lame-duck session, Cassidy laughed.
“Would I bet my house on it? No,” he said. “Would I bet your house on it? Of course.”