A Bill for Experimental Drugs 💊

 Photo: Marco Ugarte / AP

Photo: Marco Ugarte / AP

'Right-to-try' law

President Trump has signed the ‘Right-to-Try’ bill into law. The bill was approved by the Senate several months ago and passed the House last week. Advocates for the bill are praising it for its potential to save many lives. Opponents of the bill are wary of the effects that unproven drugs can have on these critically ill patients.
 

What is 'Right-to-try'?

  • It allows experimental drugs to be used on terminally ill patients who have exhausted all existing treatment options 
  • The law mitigates liabilities of companies or prescribers that provide experimental drugs to a patient that meets the criteria

 



Supporters of the bill point out that 40 states already have a ‘Right-to-Try’ bill in place. They argue that while government regulation may be necessary, overregulation stifles innovation and the potential to save lives. They praise the bill as a “common sense” answer against government overreach. In addition, the current FDA experimental drug program is criticized for having a cumbersome approval process. Furthermore, they criticize Democrats for politicizing a bill that received legislative support from both sides of the aisle.

Opponents of the bill contend that it will give patients false hope and end up burdening them with the cost and effects of ineffective drugs. They claim the bill does not provide enough protection for patients. They also criticize the bill for not providing any financial protections for patients and for not addressing the real weakness in the current FDA experimental drug program – pharmaceutical companies being the roadblock.

Will a 'right-to-try' save more lives?

It remains to be seen if it will be more effective than the existing experimental drug program. The FDA is infamous for its lengthy approval process. Nevertheless, some sources claim the current experimental drug program has a response time of a few days and an approval rate of 99%. The weakness in the current program is that pharmaceutical companies are hesitant to provide their experimental drugs to critically ill patients. This is due to the fear that an unfavorable outcome will be reflected in the FDA review of their clinical trials. The new bill protects companies and prevents the FDA from considering these unfavorable outcomes in the approval process, but it does not mandate companies to treat these patients.

Pharma companies celebrating


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