The President-Elect Donald Trump Administration has a new website with a .gov suffix, greatagain.gov, and has updated —sort of—Trump’s intended policies for healthcare and biopharma.
First off, the website indicates its plans to repeal the Affordable Care Act (ACA), saying, “A Trump Administration will work with Congress to repeal the ACA and replace it with a solution that includes Health Savings Accounts (HSAs), and returns the historic role in regulating health insurance to the States.”
It then goes on to mention six points that aren’t necessarily clear, such as “Protect individual conscience in healthcare.”
It does say it will “Advance research and development in healthcare,” and in a line that is likely to make biopharma pay attention, if not necessarily happy, “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.”
However, with no specific mentioning of e-cigs or vaping in the new Trump update, the vaping industry should remain hopeful but cautious. The Trump Administration’s current focus of FDA reform seems to primarily target the need to speed up the FDA’s approval process for getting more meds on the market. Meanwhile, the Republican Party is not well-known for wanting to regulate or reform the pricing of prescription drugs. In short, they historically like the idea of Big Pharma getting more drugs on the market at a faster rate but have no real desire to control or limit the prices.
One thing the bill proposes is increased funding for the National Institutes of Health (NIH) and clinical research. But it also proposes changes to how drugs are approved, increasing the use of surrogate markers. Forbes notes, “Monitoring biochemical markers as a stand-in for disease progression has been useful for hepatitis and HIV treatment, but has been disastrous in other areas, like statins, diabetes, oncology and hormone replacement therapy.”
It also appears to weaken safety regulations for medical devices, but also make experimental drugs more available to patients—which brings its own set of complications both ethically and financially, for biopharma companies involved in clinical trials.
WHY THIS COULD BE GOOD FOR THE VAPING INDUSTRY?
Big Pharma wanted to eliminate the competition – the vaping industry – but there is one thing they wanted even more. They wanted to avoid drug price regulation by the Democrats related to the then-impending passage of Obamacare and the Affordable Healthcare Act. As a result, Big Pharma was spending billions of dollars fighting Obamacare without much regard to the vaping industry. That is, until Obama cut them a deal.
Obama said that Big Pharma would only have to reduce their prices a little, but in exchange, they could place one of their Head Honchos in charge of the new branch of the FDA called the Center for Tobacco Products. Big Pharma chose Mitch Zeller from GlaxoSmithKline, and the Obama Administration gave him full reign over the new agency. And Mitch Zeller is the man most responsible for creating the new FDA deeming regulations that threaten to wipe out the entire vaping industry by 2018.
Big Pharma is one of the most powerful adversaries of the vaping industry. Once e-cigarettes became wildly popular over the past decade, the revenues from traditional nicotine replacement therapies like nicotine gum, lozenges, and “the patch” began to decline. Those alternatives are manufactured and distributed by Big Pharma companies like GlaxoSmithKline and Johnson & Johnson.
If Trump repeals and replaces Obamacare with something more Big-Pharma-friendly, perhaps he can also convince companies like GlaxoSmithKline and Johnson & Johnson to lay off the vaping industry as a quid-pro-quo. Trump hates smokers, and Trump loves making deals. Even better, Trump seemingly hates Obama, and the FDA deeming regulations were Obama's baby.
If the vaping industry can rally and organize in time to take advantage of this tremendous window of opportunity to educate the Trump Administration on the numerous public health benefits of vaping and e-cigs, then the sky is the limit. But the time to strike is now. The window of opportunity is closing fast.