What’s next in the Rick Bright saga?

Rick Bright, the BARDA chief who was recently demoted, has promised to file a whistleblower complaint with the Office of Special Counsel. His allegations, which include that he was ousted for refusing to promote widespread use of the unproven Covid-19 treatment, hydroxychloroquine, have also prompted two separate congressional requests for an investigation by the HHS Office of Inspector General. For more on what we know about Bright’s allegations, check out my recent story here.

Who will investigate?
The Office of Special Counsel, or OSC, is likely to take the lead investigating the Bright allegations. While there are already calls for the HHS inspector general to get involved, a spokesperson for the agency IG told STAT that when a government official files a complaint with both offices, their office generally defers to OSC. OIG declined to comment on the Bright case directly.

OSC is an independent federal agency dedicated almost exclusively to investigating claims of retaliation. They dealt with more than 6,000 similar cases in fiscal 2018. The office is headed by Henry Kerner, a veteran staffer of the House Oversight Committee and the Senate Permanent Subcommittee on Investigations.

So what’s next?
After Bright formally files his complaint, OSC will likely launch an investigation into Bright’s claims, which could take more than a year to resolve. Often if OSC finds a whistleblower was retaliated against, it will try to get that person their job back. The office also often attempts to negotiate a cash settlement with the whistleblower. In rare instances, OSC can also discipline agency officials who were caught retaliating against a whistleblower.

The first issue the office is likely to try to resolve: Whether Bright can stay in his job at BARDA as the investigation is conducted. Bright, in a statement through his lawyers, has already said he will ask OSC to take that step.

Curious what type of info OSC is likely to investigate? Here’s a hint
You can be sure that Bright’s lawyers and the government are likely to fight about whether the former BARDA chief deserved a demotion regardless of his alleged stance on hydroxychloroquine. That’ll be key to proving whether there was what the government calls “a legitimate non-retaliatory reason” for Bright being forced to change jobs.

For a preview of the fight to come, it’s worth checking out Bright’s most recent performance review. Bright, like many federal employees, was judged on a series of “critical elements” that include “leading change,” “leading people,” “business acumen,” “building coalitions,” and being “results driven.” He received the maximum score in every category except “leading people,” and received a total “score” of 480 out of 500, which the federal government considers an “outstanding” result.

“Dr. Bright continues a very successful tenure in leading BARDA,” the performance review states. Bright, it continues, “has certainly proven the ability to successfully develop, acquire and license medical countermeasures” and “has effectively worked with the private sector building trusted business partnerships.”

One more juicy tidbit
If you’re like me, and eager for all of the gossip around the hydroxychloroquine, I’d suggest you check out a new interview my colleague Ed Silverman did with FDA’s top drug regulator, Janet Woodcock, where Ed asks Dr. Woodcock if she had any second thoughts about the FDA’s controversial emergency authorization for the drug, and she responds with: “Given the circumstances, I would say we did the best we could.”

The Trump administration’s new plan for tests

The White House unveiled its new coronavirus testing strategy in a light-on-details “blueprint” Monday. And at a press briefing last night, Vice President Mike Pence pledged to achieve a nationwide testing capacity of 2 million per week by the end of next month — an impressive undertaking that, nonetheless, is at the low end of what public health experts estimate is needed to safely restart the U.S. economy. More from my colleague Lev Facher here.

Lawmakers look at revamping the Strategic National Stockpile

A trio of bipartisan bills before the House Energy and Commerce Committee would dramatically overhaul the Strategic National Stockpile, the federal government's emergency reserve of medical equipment that has struggled to supply health care workers with needed supplies of masks, protective gear, and ventilators.

One bill would allow the stockpile to accept donations of money and supplies without receiving prior authorization from HHS — though donated drugs would still need an emergency use authorization like the one central to the Bright controversy. Another bill would let the stockpile sell unneeded supplies so SNS officials could re-invest the proceeds, and a third bill would allow for expanded public-private partnerships and larger incentives for companies to work to keep the SNS fully stocked.

The legislation is the latest sign of frustration aimed at the SNS by both Democrats and Republicans. Governors have complained that N95 masks delivered to their states by the SNS have been expired and unusable. President Trump, whose administration has overseen the SNS since he took office more than three years ago, has accused the Obama administration of leaving him with an "empty shelf."

The latest industry win in the time of coronavirus:

A federal court last week approved an extension on the looming deadline for e-cigarette companies to submit formal marketing applications to the FDA. The FDA itself requested the extension, apparently convinced by the tobacco industry that a delay was necessary given the coronavirus. Tobacco companies argue the labs they are using to finish their applications are temporarily shuttered.

The move inflamed public health groups, which already sued the FDA in March 2018 for delaying previous deadlines. It was that lawsuit that created the original May 12 deadline. Now, it’s all due in September.

“This was simply another excuse for delay,” said Matthew Myers, the head of the Campaign for Tobacco-Free Kids, one of the groups that sued the FDA. “I find it highly circumspect that any significant number of e-cigarette manufacturers were really in the middle of conducting studies that they could not finish.”

Myers told STAT that if he had his druthers he would only have granted an extension for companies that could prove coronavirus was impacting their in-progress applications.

DeGette and Upton are at it again

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), the architects of the sweeping medical innovation law known as 21st Century Cures are hoping to have a sequel introduced by the end of the year, the duo told reporters Monday.

The lawmakers also released a concept paper on the Cures 2.0 bill. You can read it here. Here are my takeaways:

The coronavirus pandemic may build momentum for the legislation.

The Cures 2.0 concept paper includes a number of coronavirus-focused provisions, including requiring a national testing strategy for current and future pandemics. DeGette and Upton said they plan to pitch lawmakers on including these provisions in the Congress’ next coronavirus response package. DeGette, in fact, mentioned that lawmakers are putting together a memo now for leadership of the Energy & Commerce Committee on what provisions of Cures 2.0 should be included in that larger package. It’s a smart political move: It’ll give DeGette and Upton a chance to claim victory, and socialize the idea of Cures 2.0 as they begin the likely long and arduous process of crafting the larger bill.

CMS modernization: TBD.

DeGette and Upton have signaled that Cures 2.0 will help ensure CMS quickly covers medical breakthroughs. The concept paper provides some hints at how lawmakers plan to do that, such as by requiring FDA and CMS to coordinate on any product that receives so-called “breakthrough designation.” But the lawmakers make it clear they’re still not sure how to fix CMS. Instead of laying out policies for “CMS modernization,” the concept paper asks seemingly basic questions, like “Are there barriers that impede or otherwise slow coverage for new cell and gene therapy products? If so, what are they?” The CMS section of the concept paper is the only section that asks questions rather than laying out concrete policies.

Digital health will be a winner, but how big of a winner?

DeGette and Upton have promised Cures 2.0 will help foster the growing health tech sector. But Monday’s concept paper didn’t include the sweeping policies one might expect from the authors of Cures 1.0. Instead, the legislators are eyeing requiring guidance from the FDA on various digital health topics, like the use of digital health technologies in patient-focused development of products. We’ll be watching to see if digital health lobbyists can push the lawmakers to think bigger as Cures 2.0 progresses.

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