The Food and Drug Administration (FDA) regulates human cell, tissue, and cellular and tissue-based products, or HCT/Ps, under a unique regulatory regime set forth in 21 C.F.R. Part 1271 (Part 1271). An HCT/P that meets certain requirements is eligible for regulation as a “361 HCT/P.” …
Over the last few years, FDA has clearly prioritized efficient generic development (see, for example, the Drug Competition Action Plan). While FDA hosted public meetings, published MAPP revisions, and compiled lists of off-patent/off-exclusivity drugs, Congress reauthorized the Generic Drug User Fee Act in 2017 and …
California Last week, U.S. District Court Judge Morrison C. England Jr. denied the state of California’s motion to dismiss PhRMA’s lawsuit challenging SB 17, which was signed into law in October 2017 and became effective on January 1, 2018. (Our summary of SB 17 is available …
Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a 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 enforcement …
The American Conference Institute’s (“ACI’s”) popular “Paragraph IV Disputes Master Symposium” is coming up again! The conference will take place from October 3-4, 2019 at the W Chicago in City Center, Chicago, IL. ACI has put together an excellent program for conference attendees that include presentations …
In a much-anticipated decision for those that have been following the saga of whether FDA has appropriately set the test for determining how it may include bulk substances on its list of substances that may be used in compounding under Section 503B of the Federal …
Developing drugs for kids with rare diseases is important work. If you would like to hear from one of these kids, check out this video: “My Philosophy for a Happy Life,” by the late Sam Berns. Offering priority review vouchers to sponsors that develop new drugs …
As we have previously reported (see here, here, and here) four states (Vermont, Colorado, Florida, and Maine) have passed laws to establish drug importation programs. Reversing long-standing policy, the U.S. Department of Health and Human Services (HHS) announced on Wednesday, July 31, 2019 that HHS …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 34th iteration – is scheduled to take place from September 18-19, 2019 at The Bostonian Hotel, Boston, MA. The conference is billed as the premier event to provide folks with a roadmap …
On July 8, 2019, U.S. District Court Judge Amit P. Mehta struck down a recently finalized Centers for Medicare & Medicaid Services (CMS) rulethat would have required drug pricing disclosures to be included in television advertisements for certain prescription drugs and biological products (the “Price …
While the federal government continues to debate the hot topic of drug prices, states continue to pass new laws designed to tackle drug pricing, price reporting, and discounting. We’ve previously reported on the laws passed in California, Connecticut, Louisiana, Maryland, Nevada, New York, Oregon, Vermont …
Last week, Global Genes, a global rare disease patient advocacy organization, announced the 2019 RARE Champion of Hope Awardees, which included Hyman, Phelps & McNamara, P.C.’s very own, James Valentine. This is a great honor, bestowed upon “true champions for rare disease”, “people who inspire …
In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government. Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …
The pharmaceutical industry has filed a lawsuit challenging a recently finalized rule from the Centers for Medicare & Medicaid Services (CMS) which requires drug pricing disclosures in television advertisements for certain prescription drugs and biological products (the Final Rule). In an effort to block the …
The government lost a significant battle in its aggressive prosecutions of individuals involved in the New England Compounding Center (NECC) disaster, in which the vilified, and now-defunct, NECC “compounded” contaminated batches of drugs that led to a multitude of deaths and injuries. Gregory Conigliaro, a …
