Biotech patent attorneys rejoice – no matter if you represent generic companies or NDA holders, the 5-4 decision of the Supreme Court upholding the “individual mandate” – not under the commerce clause, but as an appropriate use of Congress’ power to tax - means that all the CLE charges you incurred to attend seminars on the future of generic biologics was not wasted. (A copy of the decision and dissents is available at the end of this post.) If the “Patient Protection and Affordable Care Act” had been voided in its entirety, the path to generic biologics that was included in the Act in some detail would have vanished (Title IV, subtitle A). I summarized the features of the Act in my post of March 26, 2010 and posted an alert on March 29, 2012.
I am not versed enough in regulatory law to opine on how, or if, the FDA would have continued to promulgate regulations and hold hearings on this touchy subject, but given that bureaucracies seldom opt for more work without direction from Congress, my guess is that the current process would have simply gone into limbo. I welcome your opinions on the way forward, but amidst the furious debate about whether the Act would waste or save the taxpayers’ dollars, it cannot be denied that generic versions of older biologicals would save patients a lot of money.