The U.S. House of Representatives passed “right to try” legislation that would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications, ending a drawn-out battle over access to unapproved therapies.

Now the legislation needs approval from the Senate. If so, President Trump is expected to quickly sign the measure, which was praised by supporters as a lifeline for desperate patients but denounced by scores of medical and consumer groups as unnecessary and dangerous.

The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process.  Drug manufacturers would have to report “adverse events” — safety problems, including premature deaths — only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval.

Patients would be eligible for right-to-try if they had a “life-threatening illness” and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.

One Congressman opposing the bill argued that eliminating FDA oversight would “provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients,” noting that the bill is opposed by over 100 patient advocacy and consumer groups.

Right-to-try laws exist in 40 states — including California. But this federal bill would introduce legislation across state lines. Right To Try was signed into law in California (Assembly Bill No. 1668) by Governor Jerry Brown on September 27, 2016. It allows very sick patients to plea for experimental treatments directly from drug companies, instead of waiting for years for drugs to hit the market or asking the Food and Drug Administration for early access.

But patients and advocates said the California law does not function well without a federal counterpart. As it stands, if someone experiences adverse effects while taking a drug acquired through California’s Right to Try policy, the FDA can pull the treatment from the clinical trial process. The mismatch has made drug companies reluctant to participate.

The federal right to try law would make California law more effective, or eliminate the need for the California law altogether