18.06.05 Right to Try

June 6, 2018
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“… thousands of terminally ill Americans will finally have the help, the hope, and the fighting chance … that they will be cured, that they will be helped, that they’ll be able to be with their families for a long time.”

Pres. Trump at the May 30 signing of the 'Right to Try' bill, aimed at helping the 1M+ terminally ill patients who die each year access drugs pending final FDA approval.

The ‘Right To Try’ Law

  • Allows terminally ill patients in the 12 states w/o a ‘Right to Try law’ to sidestep the FDA.
  • Now, patients can reach out to directly to drug manufacturers in order to participate in clinical trials & access experimental drugs.
  • Drug must pass FDA approval phase #1.
  • Eliminates existing FDA application requirements.

Why Does This Matter?

Current State: FDA Trials

  • Extremely co$tly.
  • Multi-stage process lastsA 3-7 yearsA on average, but some take even longer.
  • On average, a new cancer drug spends 14 years being studied and undergoing clinical trials BEFORE it gets approved.

Something To Consider

“Right to Try” does NOT guarantee ACCESS or AFFORDABILITY

  • Insurance companies are NOT required to cover experimental treatments.
  • Drug manufacturers are NOT mandated to undergo clinical trials OR provide experimental drugs OR produce large enough amt of drugs to ensure availability.

Under its Expanded Access (Compassionate Use) program, the FDA already authorizes over 99% of expanded access requests it receives. But for some, it's still not fast enough. Read more about the program here:

In October 2017, Scott Gottlieb, the FDA Commissioner before the Subcommittee on Health, Committee on Energy and Commerce, US House of Representatives about efforts to expand access to investigational drugs and biologics for terminally ill patients, saying:

In recent years, FDA has received over 1,000 applications annually for expanded access to treat patients with investigational drugs and biologics. FDA authorizes 99 percent of these requests. Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days.”

by Jenna Lee,