THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • On Friday, writing for The Hill, Matthew Lane, executive director of the Coalition Against Patent Abuse, called on Congress to reexamine the Orphan Drug Act (ODA) and pass an in-case-of-emergency alternative. In his must-read op-ed, Lane examines how the ODA is ill-suited for addressing the global COVID-19 pandemic and highlights the need for an alternative solution.
  • “Congress must reexamine the Orphan Drug Act to ensure that it is not being abused for unintended purposes. Second, Congress must make sure that our drug system is capable of responding to the special needs of a pandemic. While Gilead’s decision to rescind its application for orphan drug status was appropriate, they never should have had to apply for it in order to quickly and promptly bring a treatment to market during a pandemic. Fortunately, the FDA was able to expedite review of Remdesivir on its own authority, but clear pathways may be necessary to respond to such a crisis in the future. We desperately need a “break in case of emergency” option for quickly and promptly approving treatments during a crisis that encourages and rewards innovation but ensures that corporations cannot claim more than their fair share.” – Matthew Lane, Executive Director of the Coalition Against Patent Abuse
  • In a thought-provoking op-ed published last week in the Washington Examiner, Charles Duan called for a reevaluation of the importance of patents for fostering innovation during a crisis.  Duan also notes that key patent reforms are needed to prevent patent abuse and profiteering off the coronavirus.
  • “Patents are not the only way of rewarding or encouraging invention, of course. Prizes, awards, research grants, tax breaks, and subsidies are well-respected ways to entice inventors to invent. But over the last few decades, particularly starting with the passage of the Bayh–Dole Act in 1980, which allowed universities to win patents on government-funded research, patents have outstripped those alternatives as policymakers’ favorite tool for innovation policy. Both policymakers and commentators have repeatedly trumpeted patents as the superior incentive for invention over prizes and grants. What is notable about coronavirus-related innovation, then, is how absent patents have been.”– Charles Duan, senior fellow and associate director of tech & innovation policy at the R Street Institute
  • Recent reporting from Bloomberg Law sheds light on the weaknesses that the COVID-19 pandemic has exposed in the United States’ patent system. The pandemic is an unprecedented crisis and may prove to be a turning point in the fight against patent abuse.
  • “Because of Covid-19, “people will demand that we have more of a say here and around the world. Folks will get a big, highly visible dose of how pharma does business and it will fuel calls for reform.” – David Mitchell, president and founder of Patients for Affordable Drugs  
  • “The current pandemic is driving a new, broader awareness of the role of patents in drug pricing. The realization is that we can’t let intellectual property rights slow down any way of dealing with the impacts of COVID.” – Tahir Amin, co-founder of the Initiative for Medicines, Access & Knowledge

WHAT YOU SHOULD BE READING:

STAT News: Opinion: The Tension Between Public Health And Patents In The Era Of Covid-19
Christopher Morten And Charles Duan

  • President Trump and members of Congress should be wary of patent owners and their allies trying to use the pandemic to expand already strong patent protections. Some experts who represent biotech and pharmaceutical companies have called for broadening patents on diagnostic testing; other experts seek to increase the patent term for vaccines (already often as long as 25 years), and the pharmaceutical industry wasted no time inserting favorable patent language into a Covid-19 spending bill. Rather than helping the Covid-19 crisis, history shows that these changes would raise prices, reduce access to medicines and diagnostic tests, inhibit scientific research, and delay innovation.

Food and Drug Administration: Comment From Association For Accessible Medicines (AAM)
Association for Accessible Medicines

  • AAM was pleased and supportive of the FDA guidance on manufacturer communication related to biologic medicines, as well as FTC’s commitment to ensuring these communications are accurate, as expressed during the Workshop. While the biosimilars market holds significant promise, substantially more work needs to be done to ensure the development of a robust and sustainable biosimilars market. Since 2010, FDA has licensed twenty-six biosimilars, including a record ten approvals in 2019. Sixteen of these are available to patients today, but these lower-cost options face significant challenges to uptake and adoption. AAM continues to be concerned that some originator manufacturers sow seeds of doubt regarding the safety and efficacy of FDA-approved biosimilars through implicit and explicit communication to prescribers and patients through their own materials as well as their stakeholder communications.

Food and Drug Administration: Comment From Blue Cross Blue Shield Association (BCBSA)
Blue Cross Blue Shield Association

  • BCBSA is encouraged by the collaboration between the FDA and FTC to support patient adoption of biosimilars and correct anti-competitive behaviors in the U.S. biological marketplace. BCBS Plans are committed not only to ensuring that their members can access the medicines they need, but also to addressing some of the underlying market challenges that are driving costs up for families, businesses and taxpayers alike. We believe that a competitive, biological marketplace with robust biosimilar product options is one method to improve consumer access to and affordability of these therapies. The FDA Biosimilar Action Plan laid out an aggressive strategy to support biosimilar development and adoption, and many of BCBSA’s recommendations are aligned with the Agency’s strategy. We believe that a successful biosimilar market, and the biological market at large, will be judged by the: (1) safety and efficacy of its products; (2) education of prescribers  and patients; and (3) ability of competition to lower prices for consumers.

The Center For Biosimilars: AHIP Says FDA, FTC Need To Strengthen Biosimilar Effort
Skylar Jeremias

  • “If these barriers to competition are not meaningfully addressed, the biosimilar marketplace could fail to deliver on its promise of lower costs and greater patient access to vital biologic treatments,” America’s Health Insurance Plans (AHIP) said in a letter to the FDA and the Federal Trade Commission (FTC). The group said the FDA and FTC need to streamline product approvals, clarify the regulations governing biosimilars, put a stop to attempts to discourage people from using biosimilars, and start educating providers and patients about the safety and efficacy of these products.

Axios: Drugmaker Tripled The Price Of A Pill As It Pursued Coronavirus Use
Bob Herman

  • This month, Jaguar Health more than tripled the price of its lone FDA-approved drug, right after asking the federal government to expand the use of its drug to coronavirus patients. Why it matters: Jaguar Health drastically raised the price of a drug during the height of the pandemic, but executives argued the move was needed to stave off the company’s collapse. By the numbers: Going into this year, the list price of a 60-pill bottle of Mytesi — an antidiarrheal medication specifically for people with HIV/AIDS who are on antiretroviral drugs — was $668.52.

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