Pelosi’s Drug Pricing Plan Could Violate Three Parts Of Constitution, Congress’ Legal Experts Warn
And the potential constitutional issues with the bill can’t be fixed with a few tweaks — they relate to the central crux of the bill, according to a report by the nonpartisan Congressional Research Service. Meanwhile, a watchdog report flags safety and reliability concerns over drug imports from China. And in other pharmaceutical news: patents legislation, the roller coaster of Biogen's Alzheimer's drug, and an investigation into carcinogens.
Stat:
Nonpartisan Congressional Report Suggests Pelosi’s Drug Pricing Bill Could Be Found Unconstitutional
House Democrats’ signature drug pricing legislation could run afoul of not one, not two, but three separate parts of the U.S. Constitution, Congress’ own legal experts write in a new report.
The Oct. 21 Congressional Research Service report obtained by STAT states that H.R. 3, which would allow the government to negotiate over drug prices and levy huge fines on companies who refuse, might run afoul of the Fifth and Eighth Amendments, as well as Congress’ taxing power under the Constitution. (Florko, 10/25)
Politico Pro:
Draft Report Warns Congress About Pharma Imports From China
A draft government watchdog report raises alarm about the safety and reliability of pharmaceutical imports from China and urges Congress and the administration to take action to protect the public. The recommendations include requiring drug companies to list the country of origin for active pharmaceutical ingredients, or APIs, on product labels and making importers liable for any sickness or deaths caused by the APIs or finished pharmaceutical products. (Palmer, 10/25)
Politico Pro:
'Patent Thicket' Bill Caught In Tug-Of-War Over Drug Pricing Reforms
A bipartisan Senate effort to crack down on drug companies that game the patent system to shut out cheaper competitors has become a bargaining chip in the roiling debate over pharmaceutical prices. The bill, S. 1416 (116), by Sens. John Cornyn (R-Texas) and Richard Blumenthal (D-Conn.) would authorize the Federal Trade Commission to sue drug companies if they use tactics like obtaining duplicative patents or push patients onto similar new therapies just as old products are running off patent, in order to delay cheaper copies of the medication from reaching the market. (Luthi and Owermohle, 10/24)
Stat:
An Alzheimer's Patient On The 'Roller Coaster' Of Biogen's Clinical Trial
Biogen’s decision to revisit a once-failed treatment for Alzheimer’s disease came as a shock to scientists, doctors, and investors alike. For Debby Rosenkrantz, the surprise came with a bit of hope. Rosenkrantz, 66, was a volunteer in one of Biogen’s studies on the treatment aducanumab, the studies it terminated in March after concluding the drug had no hope of working. (Garde and Feuerstein, 10/25)
Reuters:
FDA Investigating Whether Zantac Causes Carcinogens To Form In Users
The U.S. Food and Drug Administration is investigating whether the popular heartburn drug Zantac causes carcinogens to form in the bodies of users, in an effort to fully understand the risks posed by the already recalled drug, the agency's spokesman said on Thursday. The issue of whether ranitidine, commonly known as Zantac, causes levels of the probable carcinogen N-nitrosodimethylamine (NDMA) to rise in users' bodies has been raised previously by Valisure, an online pharmacy that originally flagged the potential contamination of ranitidine to the FDA. (Erman, 10/24)
