In his confirmation hearing, Dr. Stephen Hahn, a longtime cancer researcher tapped to head the U.S. Food and Drug Administration, pledged to make decisions that were based on “data and science congruent with the law.”
Hahn, the chief medical executive at MD Anderson Cancer Center in Houston, was specifically responding to questions about the vaping epidemic; however, that same approach could and should be used to address the nation’s sky-high cost of drugs.
Amid a growing clamor for the government to take action on drug pricing and partisan bickering that has brought legislative action to a standstill, the FDA, with the right leadership and administrative guidance in place, has the ability to serve as an influential player in tackling U.S. drug pricing.
While it’s true the FDA has no legal authority to control drug prices, there are some evidence-based ways in which the agency can work within its existing legal authority to lower the prices of prescription drugs -- a matter of consideration for the Senate as it weighs a vote on Hahn’s nomination in December. Here are specific actions the incoming FDA commissioner could commit to:
Green-lighting lower-cost drugs.
The FDA is a powerful government agency charged with protecting public health through the regulation of pharmaceuticals and medical products, as well as the nation’s food supply, cosmetics, and tobacco products.
The agency can only approve drugs that come to the FDA for review, but it can inject more competition into the market by indicating its support for and swiftly approving lower-cost generic medicines as well as promoting biosimilar development -- action that can be taken without Congressional approval.
Such action is guaranteed to create more affordable drugs. In fact, the FDA’s own research shows that adding generic competitors to the market can dramatically lower the price of drugs – in some cases as much as half the brand name price.
Relying on the data.
The FDA should continue to be led by science when making regulatory decisions.
The next commissioner should refuse to fall victim to brand-name manufacturers’ ploys to game the risk-mitigation process (Risk Evaluation and Monitoring Strategy, commonly called REMS).
In addition, he or she should carefully consider all available evidence before granting accelerated approval or using non-validated surrogate endpoints in approval decisions.
Just as the FDA can help reduce prices through competition, allowing expensive, questionably effective drugs on the market can raise everyone’s costs.
Making decisions with people in mind.
While the commissioner’s role is nonpartisan, high drug prices cut across the political landscape, with 8 out of every 10 people saying they believe that prescription drug prices are unreasonable, according to a May 2019 poll supported by Arnold Ventures.
LISTEN: Podcast: Drug Pricing in America Hits the ‘Point of Absurdity’
The next commissioner can act as a strong and vocal proponent for legislative policy solutions that would lower the cost of drugs by injecting competition into the market whether that’s cracking down on pay-for-delay deals that prevent generic entry or creating a legal pathway for generic manufacturers to sue brand sponsors for refusing to provide product samples.
And he or she can continue heaping scrutiny on the industry, calling out drug makers for their anti-competitive tactics aimed at preserving the status quo and their bottom lines, like abusing the patent system through the creation of hundreds of overlapping patents – often called patent thickets – to thwart generic competition.
Remaining neutral in the face of a powerful lobby.
Pharmaceutical companies have long held outsized influence in D.C. and have successfully beat back several attempts over the years to address drug pricing.
The industry’s top lobbying group, Pharmaceutical Research and Manufacturers of America (PhRMA), has been called one of the most powerful lobbying groups in the country, reporting $460 million in its coffers last year.
PhRMA uses its huge stockpiles of cash to persuade lawmakers, advocacy groups, patient groups, ad agencies and think tanks to advocate against any legislation or policy that would threaten drug makers’ exceedingly high profit margins -- and it has been remarkably successful at preventing drug pricing reform.
The new head of the FDA must be willing to distance himself or herself from pharma’s strong-arm tactics and vow to put the interests of the patients at the center of all the FDA’s decision-making.
Finally, the Senate should not rest on its laurels after confirming the next commissioner. There is still an urgent need for comprehensive policy solutions that would meaningfully lower the cost of drugs for patients and taxpayers – proposals such as capping drug prices based on the (often much lower) average paid by other first world nations or stopping pharmaceutical companies from raising prices faster than inflation.
The American people are demanding action, and there is still plenty of work to do.