Biden time. 75 days to shape the coming 750 days: Editor’s Commentary
Decisions made in Washington about the pandemic and drug pricing in the coming weeks will reverberate for years
Decisions made in Washington about the pandemic and drug pricing in the coming weeks will reverberate for years.
There is no time to celebrate or mourn the elections. The United States and the world are on the edge of a precipice and must act quickly to avoid disaster.
It is reasonable to assume that Joe Biden will be America’s next president and that it will take two months to determine which party will control the Senate.
The U.S. political contests have captivated the world’s attention, but COVID-19 hasn’t taken time off to count ballots. Infection rates are rising across the world, hospitalization and death rates will follow, and holiday travel will soon ignite new surges. In the absence of immediate implementation of non-medical public health measures and the efficient deployment of medical countermeasures when they are ready, America will be devastated.
The urgency of the pandemic and the fraught political environment mean that choices made in the 75 days before the Jan. 20 inauguration will reverberate for years.
To start with, individuals close to Stephen Hahn told BioCentury the FDA commissioner believes President Donald Trump and HHS Secretary Alex Azar plan to fire him as soon as next week. Trump and Azar are furious about his assertions of independence about vaccine authorizations, resistance to White House pressure to rush mAbs onto the market ahead of the election, and withdrawal of emergency use authorization of hydroxychloroquine.
Hahn’s missteps in the spring on COVID-19 testing, and more recent mistakes on EUA of ineffective malaria drugs and unproven convalescent plasma have caused immense damage to public health and confidence in FDA, but his dismissal could be disastrous, especially if Azar replaces him with a commissar who has even less independence and a greater willingness to put loyalty to Trump over protection of the public health.
Biopharma companies will also make decisions in the coming weeks as the first Phase III data are unveiled that could change the trajectory of the pandemic.
Gridlock has worked for industry in the past, but it may be past its best-by date.
Vaccine sponsors can’t influence the outcomes of trials that will soon yield interim Phase III readouts, but they choose how they communicate results and decide whether they apply for authorizations in the U.S. and elsewhere. Hyping results or pressing for pre-approval access, even on a small scale, based on incomplete studies would be irresponsible unless the request is backed up by incontrovertibly positive data.
Most critically, vaccine sponsors will make decisions that will affect whether and how their own randomized, controlled trials and those being conducted or planned by other companies will be completed.
It is essential for companies developing vaccines and therapies to be transparent about their data, sober and fact-based in communicating results, and diligent in avoiding premature unblinding or other actions that would hobble ongoing trials or those that will start soon. Tightly controlled vaccination of high-risk populations based on preliminary data may be justified, but only if it is coupled with the assurance that more definitive data on safety and efficacy will be produced quickly.
Congress shares the responsibility to act quickly and responsibly.
The election should have taken the political sting out of coronavirus policy, freeing Congress to enact desperately needed relief legislation to provide essential economic assistance to millions of Americans. The relief bill must include funds to help federal, state and local governments distribute and administer vaccines and therapies, as well as money for the collection of data about outcomes and safety of countermeasures that will be authorized with far less data than is required for an FDA approval.
Gridlock or compromise
The shape of drug pricing debates may also be determined during the lame duck months.
The unscalable fence around the White House will be removed by the time Biden would be inaugurated, but the angry divisions it represents will remain the defining feature of American politics.
For the life sciences, and every other segment of American society, the boundaries of public policy over the next two years will be demarcated, as they were in the Trump years, by two factors: the ability to span the chasm separating Democrats from Republicans, and the administration’s competence in pulling the levers of power that are not connected to Capitol Hill.
The biopharma industry has a narrow window of opportunity to redefine its role in Washington.
The traditional playbook calls for reinforcing the red wall and counting on Senate Republicans, whether they are in the majority or the minority, to block legislation that would force pharma to change its business models or practices.
Gridlock has worked for industry in the past, but the strategy may be past its best-by date. Trump’s embrace of international reference pricing, importation and his anti-pharma rhetoric has made it difficult for Republican senators to openly support the industry’s pricing agenda.
The other problem with relying on paralyzing parliamentary tactics is that a Biden administration could be more competent than its predecessor when it comes to using administrative actions to curb prices. CMS and other government agencies have broad powers to enact Medicare drug price control measures, assert government IP rights or attenuate IP protections, use FDA’s regulatory powers or take other steps to curtail biopharma revenues.
Administrative tools are blunt and could have unintended consequences, so it would be better for all stakeholders — patients, physicians and hospitals, insurance companies and biomedical product innovators — to find consensus on a path forward.
Rather than start with an adversarial approach and a determination to delay change as long as possible, biopharma companies could try to seek common ground with the Biden administration and both parties in Congress before all parties are painted into corners.
PhRMA came close to agreeing on a drug pricing deal with Trump’s Chief of Staff Mark Meadows before it was derailed by White House demands for industry to pay for Medicare gift cards. The agreement, which would have saved taxpayers over $110 billion over a decade, centered on drug companies agreeing to caps on price increases and changes to the structure of Medicare Part D that would reduce or eliminate out-of-pocket costs for patients.
Even if the political atmosphere remains toxic, there are areas where life sciences companies can work with Congress and the next administration. The pandemic has created an opportunity to craft consensus on enhancing pandemic preparedness, extending public-private collaboration to fighting antimicrobial resistant organisms and enhancing the resiliency of pharmaceutical supply chains.
Biden’s passionate interest in advancing cancer therapies, and the bipartisan concern about flagging American competitiveness, could open the door to forging pro-innovation policies. Investments in translational and regulatory science could lead to the creation of modern clinical trial networks based on master protocols, as well as real-world evidence systems, while public-private partnerships could fuel advances in fields like gene and cell therapy manufacturing.
Signed commentaries do not necessarily reflect the views of BioCentury.