Is Your Company Ready for the 21st Century Cures Act?

As most biopharmaceutical groups are aware, the 21st Century Cures Act of 2016 mandates a number of powerful core changes to drug and medical device development timelines. Thanks to the new legislation, breakthrough medical device and biologic therapeutics will have drastically expedited development and clinical trial pipelines.

The objective of the new legislation is to streamline medical product development overall, with two areas of specific focus: biologic therapies and medical devices.[1] The immediate effect of the legislation will be that the breakthrough drug or product designation which allows for expedited movement through the clinical trial process will be easier to disburse. This is a major change because via the 21st Century Cures Act, medical devices are now eligible for the breakthrough designation, unlike before.[2]

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The new legislation also expedites the ability for pharmaceutical companies to apply for FDA approval of previously approved drugs for new indications. This is relevant in many cases of immunotherapeutic biologics, which means that many more of these drugs can be brought to market after passing their initial trials and post-market analysis. Previously, pharmaceutical companies would need to make an entirely new investigational new drug submission (IND) with new raw data supporting the rationale for using the drug for the new indication. Now, companies need only submit data summaries and abridged reports which will allow breakthrough drugs to get to patients faster than ever before.

The 21st Century Cures Act includes new protections for patients, too. Under the act, the FDA has new purview to guide pharmaceutical companies in conducting in silico trials preclinically to ensure that trial patients won’t get hurt by easily overlooked issues.[3] Concurrent with this new emphasis on preclinical planning is a gift to the pharmaceutical companies that will have to conduct the extra work: many of the regulatory reporting requirements for clinical trials have been streamlined and modernized. Depending on the disease area and therapeutic modality, the legislation waives certain kinds of reporting altogether or provides new regulatory affairs centers to help pharmaceutical companies comply with the relevant regulations.[4]

The act also has an initiative in the legislation which directs more funding to medical countermeasures for emergent diseases, though it is small in comparison to the programs above.[5] Much like with other federal legislation of the pharmaceutical industry, compliance with the new regulations are phasing in over the course of the next few years, with finalization in 2020. Judging by the FDA’s scheduling site, there’s a lot of work to do on the program between now and then.[6]

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