As the Affordable Care Act moves closer to being fully implemented, the concern among biopharmas that ACA will adversely affect the industry continues.

At the “Affordable Care Act Is Here to Stay” panel that I attended at the BIO International Convention in Chicago last April, Kristine Peterson, chief executive officer of Valeritas, a Bridgewater, N.J.-based drug delivery device company, said, “Any time there is uncertainty or a lack of clarity about where something like ACA is headed, that creates concern in the marketplace that funding will be harder to get.”

The anticipated effect of declining levels of government reimbursement for medical treatments could radically change the drug development process, panelists said.

Peterson compared the situation to the biopharma industry 10 to 15 years ago, where she said a company could say, “I’ll develop my treatment only up to this point and either someone will license it or I’ll be bought out, so I’m not going to worry about reimbursement issues for this treatment. Someone will do the work for me.” She added, “Well, guess what? That’s not necessarily the case these days. If you have not thought about how to bill and how to prepare for eventual reimbursement, my evaluation of your asset will be lower, and the continued development of the drug may not happen.”

Meena Datta of Sidley Austin LLP said that the anticipated impact of ACA could drive companies away from certain areas of medicine. “The way the system is evolving, with the rules changing as we move along, it can make companies gun-shy and cause them to think about moving into therapeutic areas that are not so heavily dependent on federal health care programs.”