Generic drugs: the 2017 law on faster review
What they say
In the October 8 debate she said that as head of the Senate Aging Committee she looked into high drug prices, found barriers keeping lower-priced generics off the market, and wrote the law that speeds up approval of generic drugs. On October 6 she said she had worked to speed approval of lower-cost generics.
What the record shows ·
In February 2017 she sponsored S. 297, with Claire McCaskill, to have the FDA put generic drugs with little or no competition first in line for review and act on them within 150 days. A version of that section became law as section 801 of the FDA Reauthorization Act, Public Law 115-52, signed August 18, 2017: the FDA must prioritize generics of drugs with few competitors and act within 8 months, and its line letting the FDA speed up inspections of their plants is word for word from her bill. She voted for the act, which passed the Senate 94 to 1 on August 3, 2017. That day she told the Senate it carried provisions based on her bill with McCaskill, which grew out of the Aging Committee's investigation of price spikes, adopted as her amendment in committee.
Limit: Her bill became part of a larger law, not all of it, and the version that passed gives the FDA 8 months to act, not her bill's 150 days. The committee's record of her amendment was not read; the floor statement is her own account.