Senate reaches deal on FDA bill amendments

Senate Majority Leader Harry Reid (D-Nev.) announced an agreement on amendments Wednesday that will finally allow a Food and Drug Administration bill to move forward. The deal should lead to passage of the bill on Thursday, ending several days of uncertainty.

Under the agreement, the Senate will consider 17 amendments to the bill, the Food and Drug Administration Safety and Innovation Act (S. 3187), which reauthorizes a user-fee program for drug companies seeking FDA approval. The Senate will debate amendments until Thursday at 2 p.m. After votes on the amendments, the Senate will vote on the bill itself.

{mosads}The agreement marks an end to a standstill over which amendments to consider, a problem that has slowed Senate work on several bills throughout the 112th Congress.
   
“I appreciate everyone’s help and it takes everyone’s help to get where we are,” Reid said on the Senate floor after the deal was reached.

Senate Minority Leader Mitch McConnell (R-Ky.) said the deal was a “good agreement that allows us to go forward on the FDA bill with appropriate amendments.”

Under the agreement, four of the 17 amendments will require 60 votes for passage. One of these, from Sen. John McCain (R-Ariz.), would require Health and Human Services Secretary Kathleen Sebelius to issue regulations allowing the importation of prescription drugs from Canada, within six months after the language becomes law.
 
Language from Sen. Bernie Sanders (I-Vt.) would take away exclusive drug marketing rights from companies found to be guilty of fraud. An amendment from Sen. Lisa Murkowski (R-Alaska) would limit the ability of the government to approve genetically modified fish or other marine wildlife. The fourth amendment requiring 60 votes was offered by Sen. Jeff Bingaman (D-N.M.); his language is aimed at ending delays in getting approval of generic drugs.

Among the remaining amendments are two that set up a fight over how much the FDA should be able to regulate dietary supplements. One amendment from Sen. Dick Durbin (D-Ill.) would require dietary supplement makers to register with the FDA, while the other from Sen. Rand Paul (R-Ky.) would prevent the government from taking any action to limit claims that a food supplement has certain mitigating effects against diseases. 

Details on the other amendments that could be voted on follow here, although some of these were expected to be withdrawn.

Sen. Ben Cardin (D-Md.) — requiring the FDA to devise a plan to educate people about the risks of various medical products.

Sen. Charles Grassley (R-Iowa) — providing protections for the commissioned corps of the public health service.

Sen. Joseph Manchin (D-W.Va.) — to reclassify the pain reliever hydrocodone under the controlled substances act.

Sen. Rob Portman (R-Ohio) — requiring the government to establish a system for facilitating the exchange of prescription drug information across state lines.

Sen. Jack Reed (D-R.I.) — setting phased-in compliance dates for a rule on sunscreen labeling.

Sen. Tom Coburn (R-Okla.) — setting rules on employee performance awards.

Coburn — requiring an audit of the drug approval process.

Sen. Richard Burr (R-N.C.) — allowing members of Congress and their staffs to attend certain negotiations between the FDA and the regulated industry. Burr said on the Senate floor after the deal was announced that he would not force a vote on this language.