Life Science Compliance Update

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June 06, 2017

Senate HELP Committee Advances FDARA

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On Thursday, May 11, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee advanced an amended version of the Food and Drug Administration Reauthorization Act (FDARA) to the Senate floor by a 21-2 vote during an executive session. Senator Bernie Sanders and Senator Rand Paul were the two votes against the bill.

In addition to the manager’s amendment, two additional amendments were added by voice vote, including one from Senators Susan Collins of Maine and Al Franken of Minnesota that would expedite the review of some generic drug applications, and another led by Senator Orrin Hatch of Utah that would expand clinical trial criteria to allow sicker patients to participate.

Generic Approvals

Senator Collins and Senator Franken’s amendment was intended to improve access to affordable medicines by increasing the competition of generic drugs. Senator Collins noted that the language gives a clear time frame of eight months for the FDA to act on the issue and that new reporting requirements would provide transparency on the backlog of generics that are currently awaiting approval. She also noted that the amendment would require the FDA to track when drugs are exiting the market to help prevent shortages.

Clinical Trial Criteria

Senator Orrin Hatch of Utah spoke about the importance of including the Enhanced Clinical Trial Design Act. He explained that the amendment was bipartisan and proposed ways to address the way clinical trials are designed early in their development and included a wider patient mix in earlier trials. He noted that it would enhance the safety of drugs and allow patient access to effective therapies by making it easier for patients to use an FDA program to receive unapproved drugs when they do not qualify for trials.

Importation Amendment

Further, the committee voted 13-10 to table an importation amendment by Senator Bernie Sanders of Vermont that would have allowed for prescription drug importation from Canada. The amendment also received support from Senator Bob Casey from Pennsylvania, who explained that the language included several safeguards that were overlooked by the debate. He also clarified that foreign manufacturers are required to register with the FDA and only those drugs that are approved by the Administration may be imported.

Senator Hatch made clear that he did not support the amendment, declaring that it would pose serious public health concerns for Americans due to the lack of foreign site inspections by the Canadian government – over the past two years he noted that the Canadian government has only completed seventeen foreign site inspections (compared to the 842 the FDA completed just last year).

The amendment also received support from Democrat Senators Elizabeth Warren, Christopher Murphy, and Maggie Hassan.

While Committee Chairman Lamar Alexander acknowledged support of the concept, he described the amendment as controversial and asked to delay a vote on it until the bill reaches the floor to keep the committee process bipartisan. Committee Ranking Member Patty Murray and Senator Tim Kaine, both Democrats, agreed with Senator Alexander’s assessment of holding off on the vote.

Conclusion

Many Democrats used the hearing to protest the Senate process for developing a counterpart to the House-passed ACA repeal bill, calling on committee Republicans to hold hearings.

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