On December 13, 2019, Nature Reviews Drug Discovery published an article that reviews the landscape of the development of drugs for rare diseases, both the progress and challenges. The article was authored by HP&M Attorney James E. Valentine along with co-authors from the BioPontis Alliance …
Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program. FDA generally conducts …
Earlier this week, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR) and Senate Health Committee Chairman Lamar Alexander (R-TN) announced that they reached agreement on a bipartisan, bicameral drug pricing bill, called The Lower Health Care Costs Act …
The distinction between a drug and a device is a critical one: drugs and devices are subject to different regulatory schemes, with the drug pathway being significantly more onerous and expensive. User fees alone for a generic drug total $300,000 for the first year compared …
As we move in to 2020, FDA is fastidiously preparing for the event 10 years in the making: the transition. For those of you unfamiliar with the “transition,” it refers to the “deemed to be a license” provision of the Biologics Price Competition and Innovation …
As we stated in our earlier blog post, on November 21, 2019, FDA released another draft guidance addressing compounding of animal drug products from bulk substances. Recall that FDA first released its draft animal drug compounding guidance in 2015 (blogged about here). With the release …
On November 13, 2019, the National Academies of Sciences, Engineering, and Medicine (NASEM) Forum on Regenerative Medicine hosted a workshop on Exploring Novel Clinical Trial Designs for Gene-Based Therapies. The Forum was tasked with exploring the design complexities and ethical issues associated with gene- and …
In October, FDA issued a draft guidance titled “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act,” which will replace a similar April 2011 draft guidance once finalized. This new draft guidance reflects a significant expansion of FDA’s …
The Government Accountability Office released a new Report last week focusing on the oft-analyzed tactics used by some innovator or brand-name pharmaceutical manufacturers to keep generic versions of products off the market. Like some facets of then-Commissioner Gottlieb’s Drug Competition Action Plan, the GAO Report …
On November 7, 2019, gene therapy company Regenxbio Inc., filed suit in U.S. District Court in Washington, D.C. against FDA asking the court to set aside a partial clinical hold on one clinical trial and a full clinical trial for another. The complaint also seeks …
Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …
In two Federal Register notices and the denial of a citizens petition, FDA laid out a revised enforcement program for homeopathic drugs. Under the FDC Act, just as allopathic drug product, homeopathic drug products are subject to new drug requirements related to approval, adulteration, and misbranding. …
FDA recently finalized a Guidance for Industry to help guide the development of new products for patients with amyotrophic lateral sclerosis (ALS). The original draft guidance was published early in 2018 (see our previous post here). ALS, colloquially known as Lou Gehrig’s Disease (ALS forced the …
On October 1, 2019, FDA issued its second Patient-Focused Drug Development (PFDD) draft guidance – the next in a series of four methodological guidance documents, which discuss the collection of patient experience data to support decision-making related to drug development and approval (see some of …
Buried in a recently enacted continuing appropriations act for FY 2020 is a provision amending the Medicaid Drug Rebate statute as it relates to authorized generics. See Continuing Appropriations Act, 2020, and Health Extenders Act of 2019, § 1603. Under CMS regulations, NDA holders (“primary …
