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BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making discoveries that were unimaginable a decade ago. The days of traditional chemical drugs that treat broad classes of patients in blunt ways are giving way to the development of entirely new ways to treat and ultimately cure disease for targeted patient populations using living organisms, including a patient’s own cells. We have already seen the first wave of these advances reach the marketplace, with many more already in the Food & Drug Administration (FDA) regulatory process.

However, BIO and our members recognize that too many patients – even those with insurance – cannot afford the life-saving cures and treatments that biopharmaceutical companies are developing. We stand with the Trump Administration in our shared commitment to addressing this serious problem. To accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. That’s why BIO has joined with stakeholders across the healthcare spectrum – including insurers, Pharmacy Benefit Mangers (PBMs), employers, and patient groups – in a coalition that developed and supports consensus, market-based reforms to lower drug costs without harming innovation.

Dear Secretary Azar,

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Department of Health and Human Services’ (HHS’ or the Department’s) Request for Information on the Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (the RFI/Blueprint).1 BIO strongly supports efforts to help improve patient access to, and the affordability of, the amazing medical breakthroughs that our member companies are developing, and we pledge to work constructively with HHS to achieve this goal.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. BIO membership includes biologics and vaccine manufacturers and developers who have worked closely with stakeholders across the spectrum, including the public health and advocacy communities, to support policies that help ensure access to innovative and life-saving medicines and vaccines for all individuals.

BIO members represent the entire biotechnology innovation ecosystem – from universities and research institutes, to start-up biotechnology companies, to the private investors that risk massive amounts of capital to fund these companies, to the larger, established companies that play a critical role in bringing these life-changing innovations through the development and approval process and into the marketplace. Of our approximately 1,000 members, the vast majority of them are small companies engaged in some of the most challenging, cutting-edge research in the world. They typically have no marketed products and no profits, and thus are heavily reliant on private capital to fund their work. They take enormous risks every day to develop the next generation of biomedical breakthroughs for the millions of patients suffering from diseases for which there currently are no effective cures or treatments.

To that end, BIO adamantly advocates for patient access to the most appropriate therapy available, and agrees with the Administration that more can and should be done to lower patients’ out-of-pocket (OOP) costs so that patients can access their prescription medicines. We are interested in continuing to actively engaging with the Department to ensure that any changes to the current system meet the Administration’s goals of improving competition, supporting better negotiation, and reducing OOP spending for patients without disrupting patient access or hampering future innovation. As the Administration considers these issues, it is important to acknowledge which parts of our system are currently working well, and to look for opportunities to build upon those successes to the benefit of patients, while also spurring innovation.

First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making discoveries that were unimaginable a decade ago. The days of traditional chemical drugs that treat broad classes of patients in blunt ways are giving way to the development of entirely new ways to treat and ultimately cure disease for targeted patient populations using living organisms, including a patient’s own cells. We have already seen the first wave of these advances reach the marketplace, with many more already in the Food & Drug Administration (FDA) regulatory process.

However, BIO and our members recognize that too many patients – even those with insurance – cannot afford the life-saving cures and treatments that biopharmaceutical companies are developing. We stand with the Trump Administration in our shared commitment to addressing this serious problem. To accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. That’s why BIO has joined with stakeholders across the healthcare spectrum – including insurers, Pharmacy Benefit Mangers (PBMs), employers, and patient groups – in a coalition that developed and supports consensus, market-based reforms to lower drug costs without harming innovation. Through the Council for Affordable Health Coverage (CAHC), BIO and our allies are working to:

  • Increase marketplace competition by speeding regulatory approval of more innovative drugs, and promoting greater and faster generic and biosimilar entry once patents and exclusivities for innovator drugs have expired;
  • Move towards a drug payment system that is based on value and patient outcomes rather than volume, by removing regulatory and legal barriers that hamper value-based arrangements and communications between innovators and payers;
  • Empower patients and providers with more information on formulary coverage, OOP costs, and value to help them make more informed choices; and
  • Oppose ideas that would impede innovation like price controls, drug importation, or direct government "negotiation" of drug prices in Medicare.