5 Key Questions for Health & Human Services Secretary Nominee Xavier Becerra

Question 1: As Secretary of Health and Human Services, will you commit to using mechanisms such as march-in rights and the statutory authority of Section 1498 to ensure that pharmaceutical companies don’t continue to give Americans a bad deal and bar access to life-saving treatments and vaccines that they are true investors of?

Background: Studies have shown the significant role of federally funded research to the development of life-saving treatments and vaccines. One study found that every new molecular entity approved by the Food and Drug Administration between 2010 and 2019 utilized funding from the National Institutes for Health. In the case of COVID-19 drugs, diagnostics, and vaccines, federal agencies have poured in billions of dollars towards their development and later, their procurement. Effectively, American taxpayers are paying at least twice for these critical health technologies that they ultimately funded in the first place. As a striking example, Moderna’s vaccine was funded completely from bench to bedside by the federal government, yet the company is charging the U.S. government billions of dollars to provide doses to patients. Even Pfizer’s vaccine benefited from NIH research and funding for its development. Only during the “pandemic period” have companies committed to lower prices for these vaccines and for therapies such as the monoclonal antibodies and antivirals, prices are exorbitantly high and without clear relation to their actual value. Even before the pandemic, 1 in 4 Americans reported difficulty affording the medicines prescribed to them by their doctors. Now with the pandemic forcing millions of Americans out of work and without any health coverage, their access to their prescription drugs has only worsened.

Follow-up to Question 1: The U.S. government must ensure increased affordability of any new publicly-funded medical treatment or technology. COVID-19 is a global pandemic that requires a global response. A recent analysis found that one-quarter of the world may not get a COVID-19 vaccine by 2022. Will you as HHS Secretary commit to ensuring that federally-funded biomedical research and development grants include terms and conditions that require affordability and availability of products in low- and middle-income countries, and affordable pricing requirements for the U.S, by requiring broad use of non-exclusive licenses, enabling generic competition? Will you also support the United States’ participation in the COVAX Facility (set up by the World Health Organization, Gavi Alliance, and Coalition for Emergency Preparedness Initiative) to ensure global access to the COVID-19 vaccine?

Question 2: As Secretary of Health and Human Services, would you support using mechanisms such as compulsory licensing and public manufacturing to ensure affordable and adequate supply of all necessary treatments and vaccines, including for COVID-19?

Background: The lack of generic competitors for expensive, brand-name medications not only raises questions around affordability, but also around adequate supply. This past summer, shortages were seen across the country for the antiviral drug, remdesivir, manufactured by Gilead Sciences used to treat COVID-19. Even before the pandemic, state governors (Governor Gavin Newsom) had proposed the idea of public manufacturing for generic medications to help curb costs and bills have been introduced in Congress to allow for such a mechanism to ensure adequate supply, especially during a pandemic. In order for President Biden to meet his aim to distribute 100 million vaccines in 100 days, he must employ the full use of the Defense Production ActSection 1498, and march-in rights to ensure timely access to COVID-19 vaccines.

Question 3: As Secretary of HHS, will you support eliminating the non-interference clause and do everything in your power to support Medicare leveraging its collective buying power to negotiate directly with pharmaceutical corporations to lower the cost of all prescription drugs?

Background: Medicare is the world’s largest buyer of medications and yet our seniors pay some of the highest prices in the world. The Medicare Modernization Act of 2003 includes a provision known as the noninterence clause which states the HHS Secretary “may not interfere with the negotiations between drug manufacturers and pharmacies and PDP sponsors, and may not require a particular formulary or institute a price structure for the reimbursement of covered part D drugs.” In a recent poll by Kaiser Family Foundation, 86% of Americans support the ability of Medicare to negotiate drug prices. A recent report by the Government Accountability Office shows that Medicare Part D prescription drugs were more than double the cost of drugs for the Veterans Affairs  in 2017. During his campaign, President-Elect Joe Biden committed to ensuring that Medicare can negotiate the prices of drugs.

Follow-up: Will you commit to extending these negotiated prices to all Americans, regardless of their insurance type?

Question 4: As Secretary of HHS, will you support offering a total of 5 years of exclusivity for all biologic drugs instead of the current 12 years?

Background: It’s no secret that the high price of prescription drugs is driven by specialty drugs, which Medicare defines as drugs costing at least $670 per month in 2019, make up nearly 50% of all prescription drug spending. Many of these medications are biologics, which receive an additional 7 years of exclusivity, for a total of 12 years. This was initially enacted in Biologics Price Competition and Innovation Act because it was thought that biologic medications take a longer time to develop and costs would not be recouped in the standard patent structure. New research shows that of the 275 new drugs approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) between 2007 and 2016, the median total development times—from first patent filing to FDA approval—were about 12 years for both small molecule and biologic drugs. This is plenty of time to recoup costs for a standard 20 year patent and calls into question whether additional exclusivity is truly needed. The sooner these biologic drugs have competition, the lower their prices.

Question 5As HHS Secretary, will you ensure that NIH and FDA enforce penalties for failures to report clinical trials results?

Background: Under the US FDA Amendment Act of 2007, clinical trials registered on ClinicalTrials.gov should share results on the site within 1 year of completion, or publish in a journal. But many organizations fail to report the results of clinical trials. The FDA has the power to fine trial sponsors who do not comply but rarely does this. To date, it is estimated that the FDA could have imposed $14 billion in fines from trial sponsors who failed to or delayed sharing results.

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