Reid Calls for Lawmakers To Reach Agreement on FDA User Fee Legislation
On Tuesday, Senate Majority Leader Harry Reid (D-Nev.) warned that he would move on to other legislation if a deal is not reached over amendments to a bill (S 3187) to reauthorize and modify FDA's prescription drug and medical device user-fee programs, The Hill's "Floor Action Blog" reports (Strauss, "Floor Action Blog," The Hill, 5/22).
Reid gave the warning as he set up a procedural vote on the bill for Wednesday. He noted that if a deal is not reached, he could file cloture on the measure and move on to other legislation."[I]f we don't have something worked out, I think we're going to have to do some other things and recognize that all the happy talk on this bill might not come to be," he said.
Lawmakers have proposed a number of amendments, despite a request from the bill's sponsors -- Sens. Michael Enzi (R-Wyo.) and Tom Harkin (D-Iowa) -- to avoid anything that could hinder the legislation's advancement. The proposed amendments include:
- One introduced by Sen. David Vitter (R-La.) that would reauthorize the National Flood Insurance Program for five years;
- A proposal by Sens. Sherrod Brown (D-Ohio) and John McCain (R-Ariz.) that would allow the U.S. to import lower-cost prescription drugs from Canada (CQ Today, 5/22);
- Another, filed by Sen. Orrin Hatch (R-Utah), that would eliminate a medical device tax from the federal health reform law (McCarthy, National Journal, 5/22); and
- A proposal filed by Sen. Jim DeMint (R-S.C.) that would require the Obama administration to release all documents and correspondence with the Pharmaceutical Research and Manufacturers of America since Obama took office.
Enzi and Harkin have noted that the reauthorization must be passed well ahead of the current authorization's expiration date -- Sept. 30 -- to give FDA some certainty about its funding. Harkin on Tuesday said he is hopeful the Senate can finish work on the legislation before the Memorial Day recess.
In the meantime, the House might take up a version of the legislation (HR 5651) while the Senate is off next week (CQ Today, 5/22).
National Community Pharmacists Association Praises Provisions in User Fee Bill
The National Community Pharmacists Association in a letter to Enzi and Harkin on Tuesday praised provisions of the Senate user fee bill that would probe whether law enforcement practices are linked with drug shortages, The Hill's "Healthwatch" reports.
The group has echoed concerns raised by Sens. Chuck Grassley (R-Iowa) and Sheldon Whitehouse (D-R.I.) that certain limits placed on drugmakers by the Drug Enforcement Agency contribute to shortages. "While most of the reported shortages to date have come from the institutional settings in the sterile injectable area, community pharmacies have also experienced shortages of certain medications," the group wrote (Viebeck, "Healthwatch," The Hill, 5/22).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.