Mark Meadows: The ruiner of pharma lobbyists’ Monday mornings

Drug industry lobbyists’ heads spun Monday after White House Chief of Staff Mark Meadows told Fox News that an executive order was coming soon on prescription drug pricing.

I spoke to several lobbyists, all of whom told me they didn’t have clear intel on what the White House was eying. It’s no wonder: Trump has already tried and failed to enact most of the ideas included in the drug pricing plan his administration released in May 2018. That left a number of lobbyists speculating that perhaps the White House would try to quickly enact an already-abandoned policy via executive order.

Several suggested Trump could try to end drug rebates via order, for example, as a “win” going into the November election. A number of lobbyists also guessed that the White House may finally deliver on it’s promise to issue a “Buy American” order for certain pharmaceuticals. The general idea: Government-run health care programs, like the VA, would be required, or at least encouraged, to source certain drugs from U.S.-based factories. For more on that fight, check out my story here.

(STAT reached out to the White House and HHS for more info on what the White House is planning. The White House declined to comment and HHS referred STAT to the White House.)

Meadows insisted to Fox News that the executive order would allow Trump to make progress on issues that Congress failed to act on, but it’s not entirely clear whether Trump could use an executive order as a “do-over” for an idea that’s been stalled by Congress or his administration.

After all, executive orders are less flexible and more limited than traditional regulations or laws.

“EOs are more about the president overseeing the agencies,” said Bridget Dooling, a research professor at the George Washington Universtiy’s Regulatory Studies Center. “EOs do not bind private behavior, so the president may not lawfully require drug manufacturers to take particular actions using an EO.”

Long story short: Don’t expect Trump to mandate drug makers lower their prices before the November election. And while the president could use an EO to direct an agency like HHS to take a certain action, like ending rebates, it’s not clear what the advantage for Trump would be, because that agency would still have to follow the typical slow regulatory process.

And some important context: It wouldn’t be the first time a promised drug pricing Executive Order didn’t materialize. After all, one year ago, on July 5, 2019, President Trump promised reporters he was going to be issuing an executive order in a few days mandating a “favored nations” drug pricing policy. The order never came.

Hey FDA, worried about political interference? Here’s some advice

More and more lawmakers in Washington are voicing their concerns over whether the Trump administration will pressure the FDA to approve a coronavirus vaccine before the November election. That kind of political pressure, they say, could undermine the public’s trust in the vaccine and in science. Now, three former federal regulators — former ASPR head Nicole Lurie, former FDA principle deputy commissioner Josh Sharfstein and former FDA chief scientist Jesse Goodman — are out with a new op-ed in JAMA on how the FDA can assuage those concerns. Among their advice: Begin explaining to the public *now* how Phase III studies work and how the FDA will determine if a vaccine is effective.

The FDA took a step toward that goal last week when it released guidance to drug makers outlining clear standards for Phase III vaccine trials. Among them: that a trials must demonstrate a vaccine is at least 50% more effective than a placebo. The guidance is such a big deal that even House Speaker Nancy Pelosi issued a press statement praising it. (I’ll buy a beer, whenever I feel safe walking into a bar again, for anyone who can point to another time when a House Speaker released a statement on an FDA guidance.)

There’s still a major question, however: What happens if the FDA issues an Emergency Use Authorization instead of a full approval? The FDA has relied heavily on the authorizations, which have a much lower standard than full FDA approvals, to get other Covid-19 treatments, like remdesivir and hydroxychloroquine, on the market quickly. And the FDA’s new guidance all but makes clear that the straightforward standards it has set for traditional approvals won’t apply for EUAs.

In Monday’s op-ed Lurie, Sharfstein and Goodman suggest the FDA should use EUAs cautiously because safety issues with an EUA-cleared vaccine could further damage the public’s trust in the FDA approval process and vaccine safety overall. They suggest requiring informed consent before vaccinating someone with a vaccine cleared through the EUA process, and that the FDA should focus on rolling out unapproved vaccines to vulnerable populations, like health care workers, before allowing widespread access. For more, check out their op-ed here.

Speaking of clinical trials: More collateral damage from hydroxychloroquine mania

New exclusive analysis from STAT and Applied XL found that one in six of the roughly 1,200 trials testing Covid-19 treatments have focused on hydroxychloroquine, the unproven malaria drug personally touted by President Trump as a cure for Covid-19. That’s a startling finding, especially now that the drug has been all but disproven as a Covid-19 treatment.

As former FDA commissioner Robert Califf told my colleague Matt Herper: “If the goal was to optimize the likelihood of figuring out the best treatment options, the system is off course.”

The findings have already prompted debate among experts, including bioethicist Holly Fernandez Lynch, who suggested on Twitter Monday that institutional review boards, which are typically charged with making sure trials adequately protect patients, should also review “scientific quality.”

For more, check out Matt’s story here.

House Democrats want to flood the NIH with funding

House appropriators want to shower the NIH with $5 billion in emergency funding in fiscal year 2021, per a draft of the House’s HHS funding bill that appropriators released Monday. That emergency cash, along with a $500 million boost in the agency’s annual bottom line, would bring the agency’s total funding for 2021 to $47 billion. It’s too early to say whether the NIH will actually receive that kind of money, though: The Senate hasn’t released their funding proposal yet and appropriations bills are known to drastically change as they make their way through the legislative process and eventually to the president's desk.

House appropriators also began marking up a separate proposal to fund the FDA in 2021 on Monday night. They proposed a much less impressive funding boost of $40.8 million for the agency, which will play a central role in deciding whether to approve coronavirus vaccines and therapeutics next year.

Nearly 350 public health groups to Azar: Defend the CDC

Amid rumors that the White House is eying drastically revamping the CDC, nearly 350 public health groups are out this morning with a new letter to HHS Secretary Alex Azar demanding that he defend the organization from political attacks.

“At this sentinel moment, we urge you to affirm the invaluable role of the Centers for Disease Control and Prevention (CDC) and resist any efforts that would undermine its mission,” the letter, which was spearheaded by Trust for America’s Health, states. “Secretary Azar, the health of all Americans is at stake. We urge you to speak up and amplify the critical role of CDC and that of all public health agencies during this monumental crisis.”

For Trump-connected lobbyists, Covid-19 is good for business

A new report from Public Citizen found that at least 40 lobbyists with ties to the Trump administration have been hired to lobby on Covid-related issues. Already they’ve represented some of pharma’s biggest players, like Pfizer, Eli Lilly, AbbVie and Johnson & Johnson.

It’s no secret in Washington that connections to the president make certain lobbyists hot commodities in this town. But that isn’t stopping Public Citizen, which has long raged about the so-called revolving door between industry and government, from making a stink: They’ve already filed ethics complaints against a number of the lobbyists, including a former CMS official now lobbying for a number of drug industry clients, including Abbvie. The group argues the lobbyists violated a Trump executive order barring Trump administration officials from lobbying the government for five years.

For more on the report, check out this story from my colleague, Ed Silverman.

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