At the December 9 symposium on FDA issues for medical device companies sponsored in Waltham by MassMEDIC (the association of device manufacturers), legislation passed by the House of Representatives that would greatly assist the industry was outlined, for the benefit of more than one hundred attending industry representatives and consultants.

The House bill enhances NIH support for innovation, alters FDA criteria for med device trials by incorporating public comment, eases regulatory pathways for anti-microbiotics, grants enhanced exclusivity for new orphan drug indications for existing approved pharmaceuticals, grants priority review by senior staff for “breakthrough devices” where there is no approved alternative, expands scope of data admissible to evaluate device improvements by acceptance of peer-reviewed articles and off-shore trials, and provides a road-map for expedited exemption from need to prove efficacy for “humanitarian devices.” These changes are a useful effort to cut into the regulatory delays which the industry has suffered. (A subsequent blog will outline the current situation in dealing with the FDA.)

Specific NIH highlights: an added $1.86B innovation fund, on top of existing grant programs, for young emerging scientists and high risk research, and changes in HIPAA regulations to make health data more available for innovation.

There is a parallel Senate version that has not been voted upon and which would have to be conformed to the House bill prior to Congressional passage. Can the Congress achieve this, given its divisiveness and other agenda items, particularly in 2016, with a legislative year shortened by the presidential election?