"Right to Try" Becomes a Reality in Michigan
On Friday, October 17, Governor Rick Snyder signed the Right to Try Act, which allows patients to try experimental drugs and other treatments before they have been approved by the Food and Drug Administration (FDA). The law gives patients with advanced illnesses access to drugs that successfully cleared Phase 1 of an FDA approval. Phase 1 testing seeks to establish a drug's safety and profile and evaluates possible side effects. It involves 20-80 volunteers and lasts approximately one year.
A few highlights of the law are noted below:
- Patients are given access to experimental drugs if they are prescribed by a doctor. However, doctors are under no obligation to prescribe the experimental drugs.
- Insurers are allowed, but not required, to cover the cost of any experimental drugs.
- Manufacturers of the experimental drugs may elect to either charge for the drugs or give them to patients free of charge.
- Manufacturers, medical professionals, and health care facilities are protected from liability for harm caused by the drugs.
The Senate bill, sponsored by Senator John Pappageorge, and a companion House bill, sponsored by Representative Nancy Jenkins, received overwhelming support in both chambers: 31-2 support in the Senate and 109-0 support in the House.
While advocates of the Act see this as a way to open the door for those with terminal illnesses, others have raised concerns that the law would lead to unnecessary treatments that are harmful to patients and create a false hope of survival. The decision to begin curative treatment with an experimental drug would also impact a patient's eligibility for hospice care and benefits.
We will stay on top of developments related to this and other healthcare bills making their way through the legislature, both in Michigan and nationally. If you have any questions please contact Jennifer Van Regenmorter at 616.796.2502.
Julie C. LaVille authored this article as a Law Clerk.
Categories: Hospitals, Insurance, Physicians, Providers
Jennifer has particular expertise in health law and she represents providers with emphasis in the areas of physicians, hospice, home care and long term care, including one of the country’s largest long-term care organizations. She has a vast array of experience in teaming with providers in the areas of regulatory compliance and contracts.
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Best Lawyers® 2021
Congratulations to the attorneys of the Health Care practice group at Foster Swift Collins & Smith, PC for their inclusion in the Best Lawyers in America 2021 edition. Firm-wide, 44 lawyers were listed. Best Lawyers lists are compiled based on an exhaustive peer-review evaluation and as lawyers are not required or allowed to pay a fee to be listed; inclusion in Best Lawyers is considered a singular honor. Health Care practice group members listed in Best Lawyers are as follows:
- Jennifer B. Van Regenmorter, Holland
To see the full list of Foster Swift attorneys listed in Best Lawyers 2021, click here.