Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA Health Care Daily Report, in “Outlook 2018: Pharma/Life Sciences Law and Policy,” by Bronwyn Mixter, Jeannie Baumann, Dana A. Elfin, and Greg Langlois. (Read the full version – subscription required.)
Following is an excerpt:
Will the 21st Century Cures Act further its aim to boost drug and device development in 2018? That’s one of the questions the life sciences industry and attorneys are asking for the new year. The law provides extra money for research and development — including ambitious research into cancer and a landmark precision medicine project involving 1 million Americans — and spurs more use of real-world evidence to support product approvals.
Other issues to watch in 2018 include what the HHS and the NIH will do to help fight the nation’s opioid epidemic. In Congress, after a year of no action, there is still plenty of talk about prescription drug prices, and that debate could affect the midterm elections. Scott Gottlieb starts his first full year as commissioner of the Food and Drug Administration and says approving more generics will help keep prices down. …
For the medical device industry, what the FDA should do regarding laboratory-developed tests is pressing, but remains unsettled.
“The federal government, as a whole, including Congress, has been unable to come up with an appropriate regulatory pathway that both protects patients and advances innovation,” Bloomberg Law board member Bradley Merrill Thompson of Epstein Becker & Green said.
“It’s rather unbelievable that such an important issue should take so long to resolve,” he said.
