The top Democrat on the House Energy and Commerce Committee announced his strong opposition Monday to a revised version of the “right to try” bill on experimental drugs that the panel’s top Republicans introduced over the weekend.
The bill “puts vulnerable patients at risk by completely removing the Food and Drug Administration [FDA] from the review or oversight of access to investigational therapies,” Rep. Frank Pallone Jr. (D-N.J.), the Energy and Commerce Committee’s ranking member, said in a statement.
“Rather than rush to pass a bill that was hastily unveiled over the weekend without careful consideration or bipartisan consensus, we should work together to find a sensible path forward that protects patients and upholds FDA’s approval process while ensuring patients, with no other recourse, have access to investigational therapies,” he said.
{mosads}On Sunday, House Majority Leader Kevin McCarthy (R-Calif.) announced the House would vote Tuesday on the measure, which would allow terminally ill patients to request access to drugs the FDA hasn’t yet approved. They could make that request without going through the FDA.
A bill has some powerful backers.
President Trump called on Congress to pass the measure in his State of the Union address in late January. Vice President Pence has been a staunch supporter of “right to try” legislation, signing a version of it into law when he was governor of Indiana. Groups backed by conservative mega-donors Charles and David Koch have also been urging lawmakers to send the bill to Trump’s desk.
Supporters say that terminally ill patients should have all the tools at their disposal to try medicines that could help them and that the federal government shouldn’t be involved in that decision. They argue the drug approval process takes too long.
Pallone’s argument against the bill mirrors the argument of other opponents, who note the FDA has a compassionate-use program allowing physicians to request access to experimental drugs for patients; the FDA approves 99 percent of the requests in that program.
The New Jersey Democrat also said the legislation provides a “false hope” to patients, since drugmakers wouldn’t be required to provide the drugs to patients who ask for them.