Small and Mid-sized life sciences companies turn to Brad as a trusted advisor. Brad advises companies on U.S. Food and Drug Administration (FDA) regulatory, compliance and enforcement issues. His practice is focused on developing practical solutions designed to allow small and mid-size life sciences companies achieve business objectives while at the same time minimizing legal risk and ensuring compliance with a variety of legal and regulatory obligations including but not limited to the Food, Drug and Cosmetic Act; the Prescription Drug Marketing Act of 1987 as amended; federal and state false claims acts; federal and state anti-kickback statutes; Foreign Corrupt Practices Act; Open Payments provisions of the PPACA; and the Lanham Act.
- Assisting clients with the development of responses to FDA Untitled Letters, Warning Letters, and Letters of Inquiry.
- Serving as legal and /or regulatory subject matter expert on various client promotional review committees.
- Counseling pharmaceutical manufacturers on regulatory pathways related to pharmaceutical label changes and potential product liability impact related thereto.
- Counseling clients on Lanham Act and other false and misleading advertising statutes and potential causes of action against competitors.
- Developing process and procedures designed to allow small start-up pharmaceutical manufacturers comply with the various regulatory requirements of PDMA with respect to the provision of pharmaceutical samples.
- Counseling clients, based on specific business operations, of the applicability of state specific pharmaceutical and medical device manufacturer and distributor licensure and permit requirements.
- Counseling life sciences companies on the potential anti-kickback statute implications related to product discounting and rebating.
- Developing processes and procedures designed to allow small start-up life sciences companies comply with the Open Payments reporting requirements of the Patient Protection and Affordable Care Act and analogous state-specific requirements.
- Counseling clients on the regulatory requirements with respect to charging for Investigational New Drugs (INDs).
- Representation of a life sciences company in a complex indemnification dispute related to the acquisition of a medical device product line.
- Jamie Kendall, Brad Welsh & Alexandra Schulz, Trump’s Push for Direct Medicare Drug Price Negotiations Addresses Only One Piece of the Industry’s Drug Pricing Puzzle, United States Biopharmaceuticals 2017, Global Business Reports, May 2017, at 25, available at http://gbreports.com/wp-content/uploads/2017/05/US-Pharma-2017-Web-Preview.pdf.
Prior to joining The Kendall Law Firm, Brad served as in-house counsel at a small pharmaceutical company where he helped to successfully commercialize the company’s first U.S. product. Brad has first-hand experience solving the complex legal, regulatory and compliance problems facing small to mid-sized life sciences companies.
Brad graduated, cum laude, from Temple University Beasley School of Law. While in law school, Brad acted as a Research Editor for the Temple Journal of Science, Technology and Environmental Law. He also served as a judicial intern for the Honorable Timothy J. Savage of the Eastern District of Pennsylvania. He is admitted to practice law in the Commonwealth of Pennsylvania and the State of New Jersey. Prior to his legal career, Brad obtained a graduate degree in Forensic Science and prior to that he worked as chemist at a leading chemical manufacturer.