Patterns of Use and Cost for Inappropriate Radioactive Iodine Treatment for Thyroid Cancer in the United States
Year: 2015
Type: article
Abstract: distinguish between drugs according to their potential effect on patients.A more plausible explanation is that drugs receiving priority review tend to have shorter development times and the FDA approves them more quickly; thus, their patents are effective for more years after their approval.To further encourage the development of drugs that address patients' needs, the FDA could be empowered by new laws to offer an additional period of market exclusivity to drugs that are shown to have substantial clinical benefit.Since 2002, when the FDA, under the Best Pharmaceuticals for Children Act, started to grant an additional 6 months of exclusivity to pharmaceutical manufacturers completing pediatric studies of new drugs, the amount of information about the safety and efficacy of drugs in children has markedly increased.5 The 6 months of exclusivity is appended to both patents and exclusivity granted by the agency.In addition, a bill introduced in Congress in December 2014 proposes to offer 15 years of exclusivity for drugs that have the potential to address unmet medical need, under the condition the manufacturer waive its rights to the patents protecting the drug.6 Whatever mechanism is used, determining the threshold for awarding additional exclusivity to drugs with substantial clinical benefit would be challenging, and reaching consensus regarding the best approach would be difficult.As a regulatory agency, the FDA evaluates the safety and efficacy of new drugs.However, these approaches to the awarding of additional exclusivity would require that the agency make a determination about the incremental effect of new drugs in the context of existing treatment options, a responsibility that would fall outside of its current mandate and, given the high stakes, would attract substantial scrutiny.Regardless of whether market exclusivity incentives are used to further encourage the development of medications with clinical importance, physicians must help patients make informed choices about the use of new drugs.If new brandname drugs are used primarily in situations where they offer clear benefits compared with generic medications and other therapies, then patents and regulatory incentives will be working well.
Source: JAMA Internal Medicine
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2107357629