Gary Veron

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Articles

FTC continues to focus on competition in pharmaceutical markets, supports FDA guidance on biosimilars

Aug 29, 2024 | lexology.com | Philip Katz |Chuck Loughlin |Gary Veron |Komal Karnik Nigam |Ilana Kattan |Jason Conaty | +3 more

This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1] FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can...
FTC disputes new slate of Orange Book patents for weight loss, diabetes, asthma, and COPD drugs

May 6, 2024 | lexology.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron |Jason Conaty |Ilana Kattan | +2 more

On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug Administration (FDA) that the Commission is disputing 300 allegedly “improper or inaccurate” patent listings in the FDA Orange Book.
Jason Conaty - Concurrences

Apr 29, 2024 | concurrences.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron

Hogan Lovells (Washington) Counsel Jason Conaty is counsel at Hogan Lovells, based in the firm’s Washington D.C. office. He counsels clients on the regulations and policies affecting complex drug and biotechnology products from the laboratory bench to the marketplace. Jason handles FDA approvals and lifecycle management for complex and advanced therapies.
David Fox - Concurrences

Apr 29, 2024 | concurrences.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron

Hogan Lovells (Washington) Partner David Fox is a partner at Hogan Lovells based in the firm’s Washington DC. office. He is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances.
Gary Veron - Concurrences

Apr 29, 2024 | concurrences.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron

Hogan Lovells (Washington) Partner Gary Veron is a partner at Hogan Lovells, based in Washington. For more than 20 years, Gary has advised clients regarding the development, approval, and marketing of pharmaceutical and biological products. Gary is committed to helping life science companies successfully manage legal and business complexities to achieve their goals.
FTC challenges around 100 FDA Orange Book patent listings | JD Supra

Nov 10, 2023 | jdsupra.com | Jason Conaty |Ilana Kattan |Gary Veron

A New Drug Application (NDA) must include patents that claim the drug substance (active ingredient), drug product (formulation or composition), or a method of using the drug for which approval is sought or has been granted, and for which a claim of patent infringement could reasonably be asserted. FDA then lists the patents in the Orange Book for the approved product.
FTC challenges around 100 FDA Orange Book patent listings

Nov 9, 2023 | lexology.com | Gary Veron |Ilana Kattan |Jason Conaty |Bryan Walsh

The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food and Drug Administration's (FDA) administrative dispute process. The patents challenged by the FTC generally are directed to inhaler devices, multidose ophthalmic bottles, and autoinjectors.
New FDA pediatric draft guidances include proposal that could limit pediatric exclusivity grants | JD Supra

May 30, 2023 | jdsupra.com | Deborah Cho |Gary Veron |Bryan Walsh

FDA’s pediatric framework consists of a “carrot” and a “stick,” where the Best Pharmaceuticals for Children Act (BPCA) offers exclusivity for certain pediatric studies, while the Pediatric Research Equity Act (PREA) mandates pediatric studies for certain pharmaceuticals and biologics.