Senate Passes User Fee Package With Ease
This article was originally published in The Pink Sheet Daily
Executive Summary
Sanders casts the lone dissenting vote, saying it does not do enough to curb drug costs. Pay-for-delay and drug reimportation amendments fail.
After taking some time to begin debate, the FDA user fee package passed the full Senate as easily and quickly as it passed through committee.
There were no surprises during the close of floor debate on May 24. No controversial amendments were approved and final passage was decisively in favor, 96-1
, with only Sen. Bernard Sanders, I-Vt., voting against it.
In addition to making policy changes at the agency, the FDA Safety and Innovation Act also would reauthorize the prescription drug and medical device user fees and create new programs for generic drugs and biosimilars.
Sanders said in a written statement FDASIA did not adequately curb the high cost of prescription drugs in the U.S.
“I voted against this bill because it does far too little to address this crisis while it perpetuates a prescription drug system that continues to fail the American people,” he said.
Sen. Richard Blumenthal, D-Ct., was one of the three Senators who did not vote on the bill. A spokesman said he was home to attend his daughter’s high school graduation.
Blumenthal had been active in drug shortage mitigation efforts leading up to floor consideration. He sponsored amendments that would have stiffened penalties for not notifying FDA of a known shortage and prohibited market manipulation connected to the sale of drugs in shortage.
Blumenthal also criticized FDA’s response to the drug shortage problem and said Congress should do more (Also see "Drug Shortage Legislation: Sen. Blumenthal Calls For More Extensive Effort" - Pink Sheet, 29 Mar, 2012.).
It took the Senate several days to reach an agreement on the amendments that would be considered and other issues. Majority Leader Harry Reid, D-Nev., at one point earlier in the week threatened to move to other bills if no progress was made.
Ultimately, many Senators lauded the bipartisan manner in which the bill moved through floor debate.
More work on it is necessary, however. Negotiations continue on track and trace standards for drug shipments. The Senate bill included a system favored by industry, but it was intended as a placeholder and does not preempt any state laws mandating a drug tracking system. A final agreement is expected when the bill reaches the conference committee (Also see "Track And Trace Negotiations Continue As Senate Works To Cull Amendments" - Pink Sheet, 22 May, 2012.).
Among the many stakeholders showering the Senate with praise was FDA Commissioner Margaret Hamburg, who said the bill’s passage “signals support for innovation and access to safe and effective medical products.”
Attention now shifts to the House, which is expected to take up its version of the user fee package after Memorial Day.
Congressional leaders want the bill on the President’s desk before July 4 (Also see "That Was Easy: PDUFA Bill Clears House Subcommittee Without Debate" - Pink Sheet, 8 May, 2012.).
Pay-for-Delay, Reimportation Amendments Fail
The Senate approved 10 amendments overall, but none of the more controversial proposals.
Sens. Richard Burr, R-N.C., and Tom Coburn, R-Okla., withdrew a proposal that would have allowed members of Congress or their staff to observe user fee reauthorization negotiations between FDA and industry. He also withdrew an amendment that would have established a performance awards system based on FDA employees’ contribution to user fee goals.
An amendment from Sen. Jeff Bingaman, D-N.M., which would have required generic companies to win their patent challenges to qualify for 180-day exclusivity, was substantially defeated, 67-28.
The amendment received less than half of the 60 affirmative votes needed for approval.
Sen. John McCain’s proposal to allow consumers to purchase prescription drugs from approved Canadian pharmacies also failed. McCain blamed the pharmaceutical industry for mounting opposition to the amendment, but said he would revisit it.
It also required 60 votes for passage, but received 43.
Sanders’ amendment that would revoke product exclusivity if a pharmaceutical company was convicted of fraud, adulteration or other crimes, failed 88-9.
Drug Review Assessment Among Approved Amendments
After passing six amendments by unanimous consent on May 23 (Also see "Senate Faces Amendment Gauntlet As User Fee Passage Nears" - Pink Sheet, 23 May, 2012.), Senators approved four more May 24 before passing the final bill.
They would require an independent assessment of FDA’s drug review process and establish standards to allow state prescription drug monitoring systems to exchange information.
FDA also would be required to not disclose confidential information received from foreign countries, if it was asked to be kept confidential.
The amendment, from Sen. Patrick Leahy, D-Vt., appears to be related to the sharing of foreign facility inspection data. The agency wants to be able to trust inspections conducted by the European Union and other countries to lessen its own inspection burden (Also see "FDA’s Globalization Strategy Needs To Be More Aggressive, Sen. Brown Suggests" - Pink Sheet, 19 Apr, 2012.).