Wednesday Bloody Wednesday in MA for drug and device makers?

 (Sorry, U2 played in the tiny Somerville Theater last night.)

State regulators yesterday approved the final details of a new regulation limiting gifts from drug companies to docs. Liz Kowalczyk of the Globe explains it here.

The regulations, approved by the Public Health Council, are intended to implement a law passed last summer to restrict interactions between physicians and drug and device companies. Legislators have said the regulations are intended to control costs by reining in unnecessary prescribing of expensive drugs and to make doctors’ potential conflicts of interest transparent to the public.

Any company doing business in Massachusetts must comply with the regulations.

After the Public Health Department staff proposed the regulations, objections were raised by dozens of interest groups and lawmakers. Consumer groups and some legislators wanted even stricter restrictions on the behavior of companies and their salespeople, such as requiring disclosure of all research payments.

Many companies said the proposal went too far and would discourage firms from doing business in Massachusetts. Convention and hotel executives said the rules would scare away companies from sponsoring continuing medical education courses for physicians, which bring millions of dollars into Boston.

What will that look like for industry?  Mass Medic, the state’s trade group for medical device makers offers this picture. So does stent maker Boston Scientific.

Consumer groups support the law. Here are a few of the objections: PHRMA, BIO

TO WATCH: It will be interesting to see how the state enforces this part of the law now that they’ve broken clinical trials into two groups.  From the Globe:

There are two substantive changes, however. Companies will have to disclose payments to doctors and hospitals for research designed to promote a particular product, sometimes called “seeding trials”; funding for research aimed at answering a scientific question will still not have to be disclosed. 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s