House of Representatives to Address OTC User Fees

Last month we reported OTC Monograph User Fees, Pre-submission Meetings and Electronic Submissions Possible and included our latest paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions. We noted that although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become…

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FDA Seeks Input: Elimination of Regulations

In January 2017, President Trump issued Executive Order 13771 entitled “Reducing Regulation and Controlling Regulatory Costs” and Executive Order 13777 entitled “Enforcing the Regulatory Reform Agenda.” On September 7, FDA Voice reported “FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework.” Shortly thereafter, FDA began opening…

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HPV Vaccine Developers Honored With 2017 Lasker-DeBakey Award

The Albert and Mary Lasker Foundation reports that “The 2017 Lasker-DeBakey Clinical Medical Research Award honors two scientists whose technological advances enabled the development of human papillomavirus (HPV) vaccines, which prevent cervical cancer and other tumors. Douglas R. Lowy and John T. Schiller (both from the National Cancer Institute) took a bold but calculated approach toward a major public-health problem whose…

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Expedited Pathways/Higher Instance of Safety Related Labeling Changes

Mostaghim et al (BMJ 2017;358:j3837) recently published a study in the British Medical Journal that concludes that “Expedited development and regulatory review pathways can accelerate the availability of new drugs, but drugs approved through these pathways are associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk…

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OTC Monograph User Fees, Pre-submission Meetings and Electronic Submissions Possible

Although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, OTC User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings with FDA before requesting changes to OTC monographs. The process for effecting such…

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Commissioner Gottlieb Vows Action: Says Drug Makers Gaming System to Slow Generic Competition

USA Today reported on August 15 that “Drugmakers ‘game the system and game the rules’ through a patient safety program that allows them to keep generic drug companies from getting enough doses of their branded drug, said Gottlieb. Generic drugmakers need up to 5,000 doses to do the studies needed to prove their products are truly equivalent, he…

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