On the 20th January 2021, Joe Biden was sworn in as the 46th US president. Despite this being just over two weeks ago, the pharmaceutical industry is already waiting on bated breath to see what actions the Biden administration will make in regard to their industry, particularly during his first 100 days in the office.
In his election manifesto, President Biden expressed his desire to improve and continue the US’s response to the coronavirus pandemic, by upscaling vaccination manufacturing and by building a nationwide vaccination campaign. The goal is to provide a free and safe vaccine to the American people as soon as possible.
It seems that so far, Biden is staying true to his word. Just this week it was reported that, under the Biden administration, the Department of Defence and Department of Health and Human Services (HHS) have awarded $230m to medical technology company, Ellume to scale the manufacture of its at-home Covid test kits.
The kits, which were granted emergency use authorisation from the Food and Drug Administration (FDA) back in December, are said to be 95% accurate and can provide users with a Covid-19 diagnosis in just 15 minutes.
While their primary focus is understandably Covid-19, what else has the Biden administration potentially got up their sleeve for the US’s pharmaceutical industry?
After successfully speeding up clinical trials and application reviews in response to the pandemic, it’s likely that the FDA will want to keep us this new pace even when we’re no longer in pandemic-times. By taking what they’ve learned from the pandemic, they can improve their strategies to facilitate the development, review and approval of medical products, whilst also streamlining the process and ensuring safety.
For instance, the FDA created an emergency program for possible coronavirus therapies last year, known as the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are effective or harmful to human health.
Moving forward, it's expected that the FDA will continue utilising this program and others like it to develop these new efficiencies into their clinical trial and product development processes and to provide industry guidance far quicker than before. Reducing the time, it takes to bring life-changing medications to market will not only be beneficial to the pharmaceutical manufacturers but also its patients.
The sky-high prices of drugs in the US have long been a hot topic and one that the industry has faced criticism for in the past. Reducing these prices, which is unsurprisingly unpopular with many in the pharmaceutical industry, is another area that the Biden administration has shown increased interest in.
Rather than utilising the most favoured nation approach, Biden has already suggested alternative approaches to make this price reduction possible. One option includes establishing a review board to assess and recommend a reasonable price based on the average price elsewhere – known as external reference pricing. Another is to allow the import of prescription drugs from abroad, but only once the FDA has certified them as safe and linking generic prices to inflation.
While the pharmaceutical industry might not be enthusiastic about these price changes, it’s likely they will have the opportunity to voice their concerns with the Biden administration and discuss the best option for all.
However, it could be challenging for Biden to drastically reduce drug prices whilst dealing with a divided congress, even though most legislators agree that the prices of drugs need to be better controlled.
Biden was closely involved with the development and implementation of The Affordable Care Act (ACA), also known as Obamacare, when he was vice-president back in 2010. Now president himself, Biden has publicly stated that he wants to reform the ACA by “giving Americans more choice, reducing healthcare costs and making our health care system less complex to navigate.”
To achieve this, Biden wants to increase coverage benefits and help make healthcare more accessible for all. For example, he’s suggested lowering the age of Medicare eligibility from 65 to 60 and wants to create a new national public option for those not already enrolled in Medicare or Medicaid.
Thankfully it seems that this could be a change that is welcomed by the industry. After completing their own research into Biden’s plans, PricewaterhouseCoopers (PwC) has stated that Biden’s plans related to increasing coverage and creating richer benefit plans could be a positive step for pharma. The author of this research
Simply put, “pharmaceutical leaders care about insurance and coverage because they need paying customers with health insurance” to fund their drugs, states PwC’s Health Research Institute leader, Ben Isgur.
Patrick Gallagher, Duane Morris partner and team lead for the life sciences and medical technologies industry group agrees has also said: “In large part, the industry wants to know what the regulatory framework is going to be so they can operate under that”. He also said that this move by Biden could bring further “certainty and stability” to the industry.
Despite already making some steady progress in regard to Covid, only time will tell if the Biden administration will achieve success with the rest of their intentions for the pharma industry.