Sarah Cork
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The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than 200,000 in the United States and for which there is no reasonable expectation that the … Continue Reading
The regulation of drug prices has received significant recent bipartisan support in Congress. Democrats and Republicans in both houses have proposed approximately eighty bills relating to drug pricing over the past two years. The charts below summarize the key provisions of representative bills.[i] Although the proposed price-regulating mechanisms differ from bill to bill, the bills … Continue Reading
The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a “revolutionary” development in medicine. This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, … Continue Reading
Among its various attempts to regulate drug prices, the Trump administration recently sought to force pharmaceutical advertisements to disclose the wholesale acquisition cost (WAC) of certain drugs. This effort was dealt a setback in June, when the D.C. Circuit found that the Department of Health and Human Services (HHS) overstepped its regulatory authority by compelling … Continue Reading
“Orphan” drug exclusivity, which is intended to reward drug companies’ investment in the development of certain drugs, might soon be harder to get—and keep. Over the past several months, Congress introduced two similar bills to amend a “loophole” in the Orphan Drug Act (ODA). On October 17, 2019, a bipartisan group of House members introduced … Continue Reading
H.R. 4712: A “Narrowly Tailored” Obligation Under the Orphan Drug Act
By Sarah Cork on Posted in Federal Rules, Life Sciences
Pre-Election Drug Pricing Regulation Efforts: Where Does Congress Stand?
By Christopher J. Spadaro and Sarah Cork on Posted in Federal Rules, Health Care, Life Sciences
Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics
By Sarah Cork on Posted in Federal Rules, Health Care, Life Sciences
HHS Can’t Force Disclosure of Drug Prices in Ads with “Blunderbuss” Rule
By Sarah Cork and Christopher J. Spadaro on Posted in Appellate, Health Care, Life Sciences
Bipartisan Congress Intensifies Efforts to Restrict Orphan Drug Exclusivity
By Sarah Cork on Posted in Federal Rules, Life Sciences
