Raul Ruiz explains vote on 21st Century Cures Act
The Food and Drug Administration would get $500 million to streamline approval processes for drugs and medical devices.
However, critics continue to argue that the proposed regulatory changes could reshape the way in which drugs and medical devices are approved in the US, making the process less costly and time consuming for drug companies; but it would possibly be less safe for patients.
“This is a patient-centered bill”.
But that effort could still be upended by last-minute concerns that the broader legislation is too much of a giveaway to the pharmaceutical and medical device industries.
“It reduces the already weak regulations on medical devices, allows drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics”, DeLauro said. Congressman Keating was also a cosponsor of the original version of the 21st Century Cures Act, which passed the House in July 2015.
That last particular measure was struck from the House-passed Cures bill and helped, alongside the mental health and opioid addiction reform, to galvanize support for the legislation. Rep. Lloyd Doggett (D-Texas) voted against the measure because he said that though the bill attempts to address the need for research funding, it doesn’t guarantee the money: “There may be bipartisan agreement, but there is not a bipartisan advancement”. They promise to propose “additional changes to the bill that are important to Democrats in order to garner strong bipartisan support”.
It provides $1 billion over two years to battle opioid and heroin abuse and includes $1.8 billion to support Vice President Joseph Biden’s Cancer Moonshot initiative, created to speed research into new cancer therapies. President Obama reportedly is likely to sign the bill into law.
The president of the American Society of Clinical Oncology (ASCO), Daniel Hayes, MD, praised the House for the passage of the bill.
Warren also took to Twitter, saying she’d fight the bill because “I know the difference between compromise & extortion”.
As a member of the energy and commerce committee and the health subcommittee, Collins was able to play a direct role in the creation of the legislation.
Meanwhile, Sanders similarly accused the bill of “numerous corporate giveaways” and like Warren, also argued that it fails to guarantee the stated funding for medical research and opioid abuse.
“Watering down sunshine provisions is counter productive and goes against the trend in health care to have more transparency, not less”, said Grassley, who said he’d block Cures’ progress in the Senate unless the provision is removed. Rep Frank Pallone Jr.
It is extremely popular with patient advocacy groups. Money directed to the NIH will be divided between the Precision Medicine Initiative, cancer research programs, and the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative.