PhRMA official discusses legislative priorities, lessons from the pandemic

The Pharmaceutical Research and Manufacturers of America (PhRMA) recently published a wish list of changes that it wants policymakers and regulators to consider to prepare for the next pandemic. A top official at the industry group spoke with Focus about these goals and what it is doing to further them.

Last week, PhRMA published slides outlining lessons it has learned during the COVID-19 pandemic and how the US can better prepare itself for a future pandemic. The group again also raised the alarm around antimicrobial resistance (AMR) that could jeopardize countless lives if current antimicrobial drugs stop working without alternatives on the market to treat infections.

Among the areas PhRMA wants to see more emphasis on is modernizing the current data and reporting infrastructure to detect, identify and mitigate emerging infectious diseases.

Jocelyn Ulrich, deputy vice president for policy and research at PhRMA, told Focus that during the pandemic, it became clear that there needed to be a better track and trace system for infections as well as a system to detect potential cases of AMR. She noted that stakeholders in the health care arena realized also that there needed to be better coordination with federal and state systems that track infections and AMR, and right now much of the duty for such work lies on the shoulders of the Centers for Disease Control and Prevention (CDC), which may need additional funding to do its job.

Ulrich noted that PhRMA has already made the case for modernizing the current system during discussions around the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and the Public Readiness and Emergency Preparedness (PREP) Act, and it will continue to do so as Congress considers reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA) before it expires in September.

“In our overarching advocacy we have encouraged lawmakers to continue to prioritize this,” said Ulrich.
“It's not like an industry specific ask [but] it's something that we believe is important for the overall functioning of the healthcare system.”

She added that the group is also encouraging investments to address the issue in the private sector, and opportunities for public-private partnerships where industry and government work together to track and address infections as they did during the pandemic.

“We haven't had a very specific ask, but as Congress considers pandemic preparedness writ at large, they should keep this on their radar,” Ulrich added.

Ulrich pointed to some of the flexibilities FDA afforded drug and device makers during the pandemic, including flexibilities around inspections and supply chain resiliency. PhRMA said it would like to ensure some of these flexibilities continue beyond the pandemic.

PhRMA said it would also like to see the US increase and strengthen public-private collaborations while also strengthening ties with its key trading partners to maintain a robust pandemic response capability and supply chain security.

Ulrich pointed to Operation Warp Speed, a public-private partnership aimed at speeding the availability of vaccines, therapies and diagnostics, and the government’s commitment to large scale purchasing prior to regulatory authorization to de-risk manufacturing. Similarly, the NIH initiated the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) project to speed clinical trials for promising treatments and vaccines. Ulrich noted that PhRMA would like to see similar partnerships between the private and public sectors beyond the pandemic.

“Generally, we are always very supportive of public-private partnerships to solve thorny problems,” she said.

PhRMA also called policies that foster research and development and advanced manufacturing. Ulrich said this ask is directed at FDA.

“There was a lot of focus in this last [Prescription Drug User Fee Act] PDUFA round looking at advanced manufacturing and building capacity at FDA to encourage more regulatory certainty around advanced manufacturing,” said Ulrich.

Ulrich also cited an “alarming increase in attempted hacks and cybersecurity breaches across the biopharmaceutical [supply] chain.” The issue highlights the need for increased investments to strengthen cybersecurity of the US medical device supply chain by improving monitoring for malicious attacks, increasing information sharing across key stakeholders and improving responses.

“We really need to be vigilant and put policies in place where we're ensuring that there is a focus on cybersecurity,” said Ulrich.

She emphasized that it’s important that whenever companies are required to share valuable information such as intellectual property with the government, the information is secure. As an example, she said that under the Inflation Reduction Act, drugmakers are required to submit sensitive information with the Centers for Medicare and Medicaid Services (CMS) so they can set prices. She said that PhRMA has asked the agency to ensure they have cybersecurity checks in place before companies must send such data.

One of the areas that companies seem to be struggling with is understanding when and how public health emergencies end and what’s required of them to keep their products on the market. PhRMA is asking policymakers to consider providing enhanced guidance on criteria and processes for declaring and ending a public health emergency.

“HHS, [Administration for Strategic Preparedness and Response] ASPR, CDC have a clear role to play,” she said. “FDA's utilization of its authorities for the emergency use authorization is still being analyzed and people are still looking at how well they utilized those authorities and do we need more clarity there.”

PhRMA also said it wants policymakers to ensure more investment and incentives to address AMR. The issue isn’t new, but the lobby group continues to be concerned about the effectiveness of existing antimicrobial drugs and the lack of incentives to develop new ones.

Ulrich notes that the 2012 Generating Antibiotic Incentives Now (GAIN) Act did create regulatory incentives for drug developers to invest in new antimicrobial drugs, but it wasn’t enough to kickstart investment.

“Unfortunately, I think what we've discovered and what has been really pretty well-accepted is that we actually have a market failure in antimicrobial products,” she said. “We don't want to have a lot of volume and because there are more inexpensive generics available on the market, we can't introduce very high-cost new antibiotics and have them accepted in the marketplace.”

Even with incentives from FDA, Ulrich said that the pipeline of antimicrobial drugs is very thin, and more companies are leaving the space. She notes a little over a decade ago there were about 18 companies working on developing new antimicrobial drugs but now that’s dwindled to just a handful.

With that in mind, PhRMA has been advocating for passage of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act which would create a subscription-like system where the US government would pay drugmakers upfront for unlimited access to antimicrobials approved by FDA.

“It would create a guaranteed market for novel antibiotics once they're approved by the FDA,” said Ulrich. “[The government] would agree to give companies a defined set of money, like a billion dollars, $2 billion over 10 years, depending on how novel the product is, and in exchange the company would make that antibiotic available to the government for any patients under Medicare, Medicaid, [Veteran’s Affairs], Tricare, et cetera. That way the company would know that they have a guaranteed revenue for this novel product.”

While the bill failed in the previous Congress, PhRMA is hoping to find lawmakers in the current Congress who will reintroduce the bill and carry it across the finish line. Again, Ulrich says the bill could be a standalone bill, but the PAHPA reauthorization bill could be a vehicle for the legislation.

PhRMA official discusses legislative priorities, lessons from the pandemic

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