To the surprise of almost nobody, the Centers for Medicare & Medicaid Services finalized their proposed direct-to-consumer advertising regulation the other day. That’s the one that would require a statement of the promoted drug’s “list price” in all DTC advertising. We’ve already discussed why we thought the regulation was on shaky ground in terms of
We saw recently that Centers for Medicare & Medicaid Services (“CMS”) has sent its proposed “Regulation To Require Drug Pricing Transparency” to the Office of Management & Budget (“OMB”). We’d heard about this proposed regulation, of course, but we hadn’t gotten around to reading it. We finally took the time.
Many readers probably
We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06. In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations. It allows manufacturers of “biomaterials” – defined as “a
The federal right-to-try (“RTT”) adventure, which we chronicled here, and here, concluded not long ago with the final passage of S. 204, signed into law on May 30. The final bill is not materially different from the house draft we analyzed earlier. The final bill cleaned up some of the previous hastily-drafted
A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of distracting those governing the country from more important matters. One version, H.R. 5247, just passed the House of Representatives. Another version, S. 204, which we reviewed in our prior post, passed
Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do. But occasionally….
The other day, Reed Smith’s Health Industry Washington Watch blog described a couple of pieces
The federal Advisory Committee on Rules of Civil Procedure released its latest Civil Rules Agenda Book on November 7, 2017. A copy of it is available here. A couple of items on the agenda should be of interest to blog readers.
The first topic has to do with proposed changes Fed. R. Civ. P.
We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under
For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets constitutional requirements. Instead, it seems bent on distracting the public from its abject failures with empty gestures.
We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute experimental drugs due to liability concerns, and these statutes don’t go far enough in removing that threat. Third, such statutes