Dr. Scott Gottlieb, President Trump’s pick to lead the Food and Drug Administration, would take over the agency at a high-stakes time when drug costs are a top concern to the public. If confirmed by the Senate as FDA commissioner, Gottlieb would face pressing questions of how to lower quickly rising prescription drug costs in a way that would be palatable to Republicans and to a president whose positions on the subject Gottlieb has criticized.
Gottlieb, who is a physician, former deputy FDA commissioner under President George W. Bush and a conservative health wonk at the American Enterprise Institute, declined to be interviewed by the Washington Examiner until after he is confirmed by the Senate. But he has written hundreds of articles in such publications as Forbes and The Wall Street Journal, which give strong clues as to how he might do his job as the country’s top drug regulator.
Here are five of Gottlieb’s positions on drug policy based on his writings:
1. To lower drug prices, regulators should ease the way for generics
Gottlieb argues that the main problem behind high drug prices isn’t the cost of new, specialty drugs but instead old drugs whose sellers can jack up the prices because there isn’t enough competition from generics.
Generic drug applications used to cost about $1 million but can now cost as much as $20 million, making it too expensive for companies to bring their competing products to market, Gottlieb wrote in a September 2016 Wall Street Journal op-ed.
In that column, Gottlieb criticized Hillary Clinton for proposing to more heavily regulate drugmakers. Clinton focused too much on drugs that are transforming the treatment of disease but also cost immense time and money to develop, Gottlieb wrote. Instead of heaping new regulations on new drugs, the FDA should focus on opening the door to generic versions of old drugs.
“It’s important to distinguish between new medicines that are priced at a premium because they represent genuine innovation and risk-taking, and drugs that are priced high simply because investors are manipulating regulatory failures,” Gottlieb wrote.
2. Allowing Medicare to negotiate the price of prescription drugs isn’t the right approach
During his campaign, President Trump advocated for allowing the federal government to directly negotiate lower drugs prices with the pharmaceutical industry, an idea typically supported by Democrats but unpopular among Republicans and pharmaceutical companies.
Gottlieb wrote that could hurt innovation in a post published last year by the Brookings Institution.
“There has been political pressure to enact policies giving federal and state governments authority to set drug prices or limit price increases,” he wrote. “However, these policies could have the unintended consequence of reducing the incentive to develop more effective drugs.”
3. Nor is allowing drug importation
Allowing Americans to buy prescription drugs imported from other places including Canada, Mexico and European countries is another idea Trump has backed and that Gottlieb has opposed.
Gottlieb has written that the added costs of regulating imported drugs would virtually erase any savings and that foreign companies would lack incentives to sell cheaper drugs in the U.S., anyway.
“The Trump plan – while perhaps good politics – will offer consumers little relief,” Gottlieb wrote for Forbes in March 2016.
4. Eliminating the system of rebates from drugmakers would help lower prices
Gottlieb has written that the current system in which pharmaceutical companies push up their list prices on drugs to afford rebates to supply middlemen is “byzantine” and “nonsensical.” The result is that insured consumers get lower prices, while those lacking coverage get stuck with the unaffordable list price, he wrote.
Congress and regulators could push for policies encouraging up-front discounts instead of rebates, he wrote.
“If insurers could demand up-front discounts, rather than back-ended rebates, and drug makers were free to offer them, then more of the markdown would come in the form of lower opening prices,” Gottlieb wrote for Forbes in September 2016.
5. The FDA needs to focus rules on higher-risk products, not regulating low-risk ones
The agency recently has spent too many resources on regulating cutting-edge technology popular among consumers but also relatively safe to use instead of actual medicines and medical procedures that carry much bigger risks, Gottlieb said last year.
“FDA has sought expansive new responsibility over everything from telephone apps, to electronic health records, to consumer gene tests and lab services,” Gottlieb said in a January 2016 speech at the International Society for Stem Cell Research.
Instead, the FDA should focus on areas such as gene-editing and regenerative medicine, he said.
“Right now, FDA is often too easily distracted by attractive areas like iPhone apps that nonetheless pose relatively low risks and could be ably addressed by other regulatory agencies,” Gottlieb said.
