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Does Maryland's "Right to Try" Bill Hurt Terminal Patients?

The Food and Drug Administration (FDA) was put into place to protect consumers from companies looking to peddle ineffectual and dangerous drugs that have not gone through extensive testing to ensure that their side effects do not put consumers unnecessarily at risk. Part of the FDA’s requirements dictate the processes that pharmaceuticals and other companies must adhere to before a product may enter the mainstream market. At the various stages of investigating the effect of a new product or drug, there are certain “guinea pigs” used to test out the effect that the drug may ultimately have on its consumers if it does manage to make it onto the market.

Role of the FDA in Experimental Drugs, Products, and Devices

The purpose of the FDA is a noble one, but at times, it may require overly burdensome procedures for drug testing when a product may take years to finally hit the shelves. This can have devastating effects for those consumers who would have otherwise been the recipients of the drug, had they not passed away before the product was released on to the market. With this issue in mind, many states are evaluating its protective practices for experimental drugs, especially in cases where the patients are terminal and likely to die otherwise.

“Right to Try” Laws in the United States

According to the Baltimore Sun, there are 33 states in the United States that have passed laws that help dying patients access experimental, medical treatments that may give them one last attempt at life. These laws are known as “Right to Try” laws.

Maryland’s “Right to Try”

Maryland recently introduced its own “Right to Try” Law outlining which patients are eligible to take advantage of this new law.

According to House Bill 584, an eligible patient under the law is one who:

  • Is Terminally ill, which is defined as a condition, disease, or disorder that will result in the death or permanent unconsciousness, without life-sustaining processes, and will most likely not recover within 12 months;
  • Has considered all other possible FDA-approved treatment options;
  • Has been counseled by a medical professional who recommended the use of the experimental drug, device, or product;
  • Has given informed consent to use the experimental drug, device, or product; or,
  • Is a minor and/or lacks the capacity to provide informed consent, but has a parent or legal guardian who gives informed consent on the individual’s behalf to try the experimental drug, device, or product.

The experimental drugs, products, and devices discussed within the bill must have already successfully satisfied the requirements of Phase I of a clinical trial, but it has not yet been approved by the FDA for consumption, and has been permitted to continue its clinical trial by the FDA. Phase I of any clinical trial is to determine the drug’s risk to the consumer, rather than the effectiveness of the drug which is evaluated in later phases.

The Benefits and Issues of “Right to Try”

There are many advocacy groups that claim that removing the restrictions would permit terminal patients to have a new chance at life and provide the administrators and researchers of the clinical trial valuable information about the effects of the drug on this population, in hopes that it might not only save these patients, but future patients, as well.

However, there are other concerns presented by patient protection groups about possible exploitation of this vulnerable population that could require investigation from food and drug ethics offices. There have been cases in which physicians and drug companies are looking to exploit and prey on these vulnerable patients and charge them pretty penny. Some patients, under the Right to Try legislation, have spent significant amounts of money on drugs that have not been proven effective, or may lead to worse quality of life.

Charles County, MD Personal Injury Lawyers that Fight for You

If your physician prescribed you or a loved one a medical treatment whose side effects have caused significant injury or death or performed a medical experiment on you without informed consent, it is important to consult with an experienced personal injury attorney. Please call the Law Office of Robert R. Castro at (301) 804-2312 for a confidential consultation.