“Right to Try” laws have been the subject of much discussion over the past few months.
In the wake of social media campaigns by family members of dying patients, states have been under pressure to pass laws that will enable patients to try experimental drugs without involvement of the Food and Drug Administration.
The Regulatory Affairs Professionals Society (RAPS) has established a Right to Try Legislation Tracker as a go-to reference for state laws. It is important for pharmaceutical executives to understand the ramifications of such laws.
The Food and Drug Administration has made a recommendation that transvaginal mesh be reclassified as a Class III device.
Previously, transvaginal mesh had been classified as a Class II device and was required to go through the 510(k) process; however, under the new regulations, it would require premarket approval.
This reclassification is the result of safety concerns that have been raised over the past six years.
Transvaginal mesh is used to provide support for damaged or weakened tissue of patients with conditions such pelvic organ prolapse.
As part of the procedure, the transvaginal mesh is permanently implanted into the patient. It then supports the vaginal walls of patients with pelvic organ prolapse. Transvaginal mesh can be made out of synthetic or animal-derived materials.
Animal-derived meshes are absorbable and degrade within a patient’s body, whereas synthetic meshes stay in the patient’s body indefinitely.
On July 31, 2014, the Food and Drug Administration announced to Congress that it will begin to regulate tests developed in a laboratory. These tests consist of those developed on a small scale in small laboratories. They include microscopic examinations (eg, Papanicolaou tests), examinations of sections of tissue, microbiology cultures, susceptibility tests, and erythrocyte sedimentation rates. They are used to diagnose conditions such as cancer, diabetes mellitus, heart disease, and Lyme disease. They differ from other manufactured tests, which are distributed to physician’s offices and are subject to regulations. This announcement is part of the agency's efforts to standardize such tests and make them safer and more reliable.
Knowing the regulatory environment in Europe is important given how many consumers live in the European Union.
The European Union has grown over the past twenty years, and it currently has twenty-eight countries as members.
The regulatory laws of these members are governed by the European Medicines Agency (formerly known as the European Medicines Evaluation Agency). The European Medicines Agency has a structure somewhat different to the Food and Drug Administration.
The European Medicines Agency has a subdivision called Committee for Medicinal Products for Human Use. This committee is responsible for scientifically evaluating the drugs that are submitted for approval. In the basis of this evaluation, the European Medicines Agency will provide a recommendation to the European Commission regarding whether to approve the product.