Happy Birthday to the Drug and Device Law Daughter. You cannot come home from Kyrgyzstan soon enough. Fall might be the season of mists and mellow fruitfulness, but it is dismal without you. And we hope you have refrained from playing Buzkashi (headless goat polo).
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Sometimes we discern patterns in our posts. Last week
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
Whenever we examine “right to try” (“RTT”) legislation, on either the state or federal level, one of the most important things we look at is whether the would-be statute provides immunity from civil litigation to our clients – the companies that invent and manufacture the potentially life-saving products that are at issue. Since none of
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
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