By Amy DeCloux, Ph.D.. A Member of our Biotech Patent Practice Group
On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain qualifications.
The patient must have been diagnosed with a life-threatening condition, have exhausted approved treatment options, have provided to the treating physician written informed consent regarding the drug, and be unable to participate in clinical trials involving the drug.
For the drug to qualify under the Act, it must have completed an FDA phase 1 clinical trial, must not have been approved for use in humans by the FDA as a new drug or as a biologic (e.g., virus, toxin, vaccine, blood component), and be the subject of ongoing development and investigation. In addition, production of the drug must not have been discontinued by the manufacturer.
The drug need not be used to treat the condition to which the FDA phase 1 clinical trial was directed. The Act protects the sponsor or manufacturer against any liability with respect to treatment with the drug, and insulates the prescriber or dispenser against liability absent reckless or willful misconduct, gross negligence, or an intentional tort. Manufacturers and sponsors are also exempt from liability for not providing drugs under the Act.
The Act exempts the manufacturer or sponsor from having to obtain initial approval from an FDA-designated Institutional Review Board to use the drug in the treatment of humans. The use of a drug under the Act will not be monitored periodically by the FDA as is the case under new drug applications. Outcomes of use under the Act will generally not be used by the FDA in evaluating the drug’s new drug application unless the sponsor requests such use.
The manufacturer or sponsor must provide the FDA with an annual summary describing the use of the drug under the Act, reporting the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events.
The manufacturer or sponsor is exempted from the need to comply with several of the FDA requirements for labeling the packaging of FDA-approved drugs. However, as with investigational new drug applications, the Act requires that the packaging of the drug state: “Caution: New Drug – Limited by Federal (or United States) law to investigational use.” The packaging must not represent that the drug is safe or effective for the purposes for which it is being investigated.
Neither the sponsor nor the investigator of the drug can promote the drug as safe or effective. Further, a sponsor cannot unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.
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