Unpacking the 21st Century Cures Act

By STEVEN FINDLAY President Obama signed the 21st Century Cures Act into law this week.  It’s the largest piece of health legislation since the Affordable Care Act.   No doubt you’ve heard or read that—and it’s true.  But while the legislation was three years in the making and much hyped, it became the best recent example of that old saying that passing federal laws is akin to sausage making:  You don’t really want to watch what goes into it. (An aside:  I made venison and bacon sausages from scratch for the first time this year and can attest to the “visceral” nature of that exercise.)  There’s something for almost everybody in this new law.   That’s one reason it was the most lobbied health bill since the ACA.  In particular, the pharmaceutical and medical device industries were big winners.  Fifty-eight drug companies, 24 device companies and 26 biotech companies lobbied the bill, spending close to $200 million altogether, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics. What they got:  a big nudge to the FDA to find ways to approve drugs and devices faster. For example, one change in the law allows FDA to accept as proof of safety and effectiveness less rigorous clinical trials, as well as other types of studies and data—both for the initial approval of drugs and to authorize new uses for drugs already on the market.  Almost every major medical society, medical school, physician ...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: blogs