Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Industry Tax, Changes at FDA, ACOs Among Key Issues for Industry in 2012."

Following is an excerpt:

''The top concern I am hearing by far is the tax on medical device manufacturers,'' said Thompson. ''At a time when there are so many pressures on companies including slower approvals and lower reimbursements, keeping the device tax on top of that is simply hurting many companies in a very significant way. I think you will see pressure mount for the repeal of the tax. ...

''FDA enforcement is on the increase, and, indeed, we are seeing more criminal prosecutions,'' Thompson said. ''Companies need to understand many of the rules better to protect themselves from FDA enforcement. The amount of compliance remediation going on is enormous.''

Reproduced with permission from Medical Devices Law & Industry Report, 6 MELR 38, 01/11/2012.

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