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A House Democrat’s effort to allow imports of cheaper prescription drugs from Canada failed in a committee voice vote June 7.
Rep. Peter Welch (D-Vt.) offered the amendment during the Energy and Commerce Committee’s markup of legislation ( H.R. 2430) to reauthorize the FDA’s user fee programs, which has bipartisan support. Welch said he was offering the imports amendment to help lower prescription drug prices, but several lawmakers said they were concerned about the safety of imported drugs.
While the committee voted down the drug imports amendment, it voted 54-0 to approve the user fee legislation, which now goes to the House floor for consideration.
The current authorization for user fees expires Sept. 30. Failure to enact the reauthorization bill this summer would mean the Food and Drug Administration would have to prepare to lay off about 5,000 employees—including 70 percent of the drug review staff.
Industry pays user fees to help fund FDA operations. In return for the fees, the agency commits to meet certain performance goals. The FDA has separate user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices.
The Senate version of the user fee legislation (S. 934) was approved May 11 by the Senate Health, Education, Labor and Pensions Committee, and awaits full Senate action.
The Energy and Commerce Committee approved six amendments to the user fee bill by voice vote, including a manager’s amendment that makes changes to the amendments adopted by the Health Subcommittee when the subcommittee approved the bill May 18.
Four of the other amendments dealt with medical device issues and one “sense of Congress” amendment offered by Rep. Jan Schakowsky (D-Ill.) directed lawmakers to work with the administration to lower prescription drug prices.
The issue of high prescription drug prices was a big focus of the committee’s markup
Reps. Frank Pallone Jr. (D-N.J.) and Kathy Castor (D-Fla.) called on the Energy and Commerce Committee to hold a hearing on prescription drug prices.
Pallone, the committee’s ranking Democrat, said ensuring patient access to affordable prescription drugs should be a top priority and this was a bipartisan issue. Castor said she noticed that the Senate side is having a hearing on drug prices. That hearing will take place June 13 in the Senate HELP Committee.
Schakowsky and Welch also said they were concerned about high prescription drug prices. Schakowsky said the committee was passing up an opportunity to do something about drug prices in the user fee bill.
Reps. Scott Peters (D-Calif.) and Ryan Costello (R-Pa.) offered two of the medical device amendments that were approved.
Peters said the first amendment would create a clear regulatory pathway for new diagnostic imaging devices intended for use with contrast agents. The second amendment addresses concerns about the quality and safety of medical devices serviced by third parties. It directs the FDA to examine the issues of third-party servicers and report back to Congress, Peters said.
The third medical device amendment, offered by Rep. Mimi Walters (R-Calif.), would require the FDA to classify a medical device accessory based on its own risk rather than the risk of its parent device.
Also, Schakowsky offered an amendment that would create a voluntary pilot program to develop postmarket safety data on medical devices.
Reps. Welch and David McKinley (R-W. Va.) offered an amendment that would prevent branded drug manufacturers from using risk evaluation and mitigation strategies (REMS) to delay generic drug launches. When offering the amendment, Welch said he would withdraw it, but asked the committee to work to pass the legislation in the near future.
The FDA sometimes requires a REMS plan from a drugmaker to ensure the benefits of the product outweigh its risks. Welch’s legislation would prohibit branded drug manufacturers from using REMS to keep generic drugmakers from obtaining samples of branded drugs needed for bioequivalence testing of the generic product.
Two other controversial amendments on off-label drug and device communications also were withdrawn.
Rep. Morgan Griffith (R-Va.) offered an amendment that would enable drug and device manufacturers to proactively discuss certain information outside the scope of FDA-approved labeling, and Rep. Brett Guthrie (R-Ky.) offered an amendment that would clarify the scope of communications between manufacturers and health-care payers.
Under long-standing policy at the FDA, companies can be subject to criminal prosecution and civil liability if they promote their products for uses the FDA hasn’t specifically approved.
In advance of the markup, consumer group Public Citizen and 12 other groups sent a letter to the Energy and Commerce Committee asking it to reject the amendments from Griffith and Guthrie. The groups said the amendments would threaten patient safety by allowing companies to significantly expand the marketing and promotion of off-label uses.
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The user fee bill is at http://docs.house.gov/meetings/IF/IF00/20170607/106096/BILLS-1152430ih.pdf.
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