House Hearing on Right to Try Bill

The federal right to try law’s next stop is the House of Representatives. The article in Kaiser Health News, House Expected To Hold Hearings On ‘Right-To-Try’ Bill That Senator Tied To FDA Funding  provides this background

The Senate quickly passed the bill that would allow dying patients access to experimental drugs after Sen. Ron Johnson (R-Wis.) had threatened to slow down consideration of a separate bill to renew the FDA’s fee-collection authority. In other drug industry news, the FDA is implementing new rules about hiring foreign scientists, industry tightens controls to keep out counterfeit drugs, cancer trials are low on patients and costs of old drugs rising quickly for Medicaid.

Although given priority by the Senate, the bill isn’t expected to get the same treatment by the House. According to an article in Roll Call,  ‘Right to Try’ Bill Could Face Slower Action in House if the House committee changes the bill from the Senate version, things will slow down.  Here’s a bit of an overview from the article:

Currently, when a patient seeks access to an experimental drug, his or her physician must work with the drug company, the FDA and an institutional review board that signs off on drug testing to approve the treatment’s use. When originally introduced in January, Johnson’s bill would have taken the FDA and other government entities out of that process. It would have let the states define “terminal illness,” potentially leading to dozens of different standards across the country about who would qualify for access. It also would have prevented the FDA from using outcomes associated with the experimental use when considering the drug’s application.

The new bill, instead of leaving the definition of terminal illness to the states, says that eligible patients should have a “life-threatening disease or condition” as defined by current federal law. It also gives the FDA the right to use outcome data if the administration determines that it is critical to assessing the drug’s safety — or if the drug company wants the outcomes used.

The drug companies would also have to provide the FDA with information about the experimental uses. Like the original bill, the new version shields companies against liability, but extends that protection to manufacturers who chose not to grant access to treatments. The bill would also limit the drugs that can be provided to those that have already completed the first phase of formal clinical trials, which are conducted to assess drug safety.