Reasonable people may disagree about whether our currently divided government is a good thing or a bad thing, especially as it relates to ability to get things done and compromise. One concern at the top of many minds may be whether the divided government will be a good thing or a bad thing for the pharmaceutical industry.
In a recent article, The Coalition for Healthcare Communication made the argument that the now highly divided and partisan Congress may actually be a concern for the healthcare communications industry. Coalition Executive Director Jon Bigelow has said, “There are a number of specific concerns for the healthcare communications industry and definitely concerns for the pharmaceutical industry.”
According to Bigelow, “industry needs to have a voice in the discussions around such hot topics as drug pricing, data privacy, FDA issues, tax issues and deregulation. ‘There’s an adage here in Washington, that if you are not at the table, you are on the menu,’ he said.”
Healthcare is expected to remain a prominent issue in the 2020 elections, which have already gotten under way. It is likely that the Republican Senate and White House continue to push for drug price transparency measures, such as reducing roadblocks to generics and biosimilars, putting list prices in drug TV advertising, and utilizing the international pricing index for Medicare Part B under a sizable “demonstration project.”
On the other side of Congress, the Democrat-controlled House is likely to hold hearings on drug pricing and call prominent industry members to testify, try to negotiate Medicare Part D prices, and push for a variety of proposals – e.g., prohibiting “pay for delay,” stripping patent rights for “excessively priced” drugs and banning direct-to-consumer (DTC) ads in the first three years after approval – that were unlikely to pass in the last Congress, according to Bigelow.
Bigelow also believes that outside of drug pricing, industry should expect action in 2019 on data privacy and marketing amidst building anger about data hacking, misuse of data and intrusive ads. The European Union’s recent General Data Protection Regulation expands the definition of personal data, allows for greater consumer consent, including opt-in, and levies severe penalties for breaches, and the state of California has established its own privacy provisions under the California Consumer Privacy Act, which could begin a wave of other state actions. “The last thing industry wants is to have to follow 50 different sets of rules for 50 different states. This, too, will have an impact on pharmaceutical marketing and communications,” Bigelow told attendees at the CHC conference.
When it comes to taxes, while the pharmaceutical industry has dodged the elimination of the ad tax deduction in the past, the possibility could re-emerge in 2019. “The reality is that the pharmaceutical industry could be a big target, and pharmaceutical marketing could be a big target,” Bigelow stated. Because Congress will be looking for bills that can move quickly, “one ‘shovel-ready’ way of gaining income in the federal government is the proposal that’s bounced up and down several times to remove the deductibility of marketing expenses for pharmaceutical products,” he said. “It’s something else we need to be watching for this year.”
Lastly, the Trump Administration has been an advocate of deregulation, and we can expect that will continue. For example, the Centers for Medicare & Medicaid Services (CMS) is revisiting the Sunshine Act’s inclusion of medical textbooks and reprints as transfers of value. “There is a real opportunity here that rules will be changed to omit that requirement,” Bigelow said.
Bigelow advised that in response to the uncertainty, industry professionals need to continue to highlight their value to the healthcare system and put emphasis on ethical, accurate work. “Do not assume it is understood by everyone,” Bigelow said. “It is not. Do not assume that it makes no difference whether people understand it. It absolutely does. And do not assume other people will speak up for us … we have to speak up for ourselves,” he said.