The FDA lost its lovin’ feeling this week, telling one bakery that “love” cannot be listed as a label ingredient in its granola. The bakery is feeling jilted by the FDA’s spurn.
Back at The Week That Was headquarters, we had another busy week (despite the fact that the words “healthcare reform” were barely uttered). We kept busy evaluating Louisiana’s new drug pricing proposal and watching not one, but two, Congressional hearings covering both Right to Try and the national opioid epidemic. We’re also tracking the short list for the replacement for the Health and Human Services Secretary—Scott Gottlieb, Seema Verma and Bobby Jindal have all been mentioned as leading candidates.
So with that, we’ll jump right in, and walk you through The Week That Was…
► NEW PROBLEMS, OLD SOLUTIONS?
The Week That Was has been following policymakers in Louisiana who are looking to a century-old law to provide solutions to a modern-day public health issue: affording medicines. The Bayou State has approximately 73,000 people living with hepatitis C who are either uninsured, insured through a state Medicaid program, or in prison. To manage the state Medicaid budget which is already strained, Louisiana is currently requiring patients to demonstrate advanced liver disease before they can qualify for access to new, breakthrough hepatitis C treatments. Patients and public health experts argue this puts them at greater risk for disease spread, cancer and lost productivity. However, Louisiana’s Health Secretary Dr. Rebekah Gee is exploring her options–and is toying with invoking 28 USC Section 1498 of US patent law. Not familiar with Section 1498? You’re not alone. Essentially, it would allow the government to authorize a low-cost “generic” version sold exclusively to the government, which would then “reasonably compensate” the patent holder. The law was last used in the 1970s to provide lower priced meds to U.S. troops in Vietnam. A favorable decision for Louisiana could mean the strategy could be used by other states.
► OUR TAKE
Louisiana continues the game of “whack a mole” the pharmaceutical industry is playing in response to state-based pricing legislation. We’ve seen bills that attempt to increase drug pricing transparency as well as pit drug price negotiations to subsidies received by the Veterans Affairs Administration. But invoking patent law in the interest of public health is a creative approach that could carry ramifications for other chronic and infectious disease medicines. With health policy stalled out in Washington, buckle up for more State proposals ahead.
► CONGRESS, FDA SHOW A LITTLE COMPASSION
Access to investigational medicines, often referred to as “compassionate use” was center stage in Washington this week. A House subcommittee examined legislation that passed the Senate last summer with support from the Right-to-Try, a libertarian movement designed to enhance the ability for people to access unapproved drugs. While the current bill would not guarantee patient access to investigational medicines, it would eliminate the FDA’s role in approving compassionate use applications. The proposed language also prohibits the Agency from slowing or stopping a drug’s review or approval based on adverse events that could occur among patients taking a treatment through compassionate use. Before his testimony to the Committee, FDA Commissioner Gottlieb announced that the Agency already scaled back its requirement on the number of physician’s needed to make a compassionate use request. The Agency also clarified 1) adverse events occurring under compassionate use are only considered if there is evidence of a causal relationship and 2) the most common obstacle to compassionate use is a company’s willingness to provide the investigational therapy.
► OUR TAKE
Commissioner Gottlieb’s comments reinforce the behind-the-scenes rhetoric developers have routinely heard from the FDA in recent years, which signaled: “we will not be to blame biopharma, for your decision to withhold compassionate use.” Over the last two years, the FDA has expedited the process for compassionate use approvals and eased administrative requirements. For drug developers, the public’s push to access investigational drugs heightens the need for clear, compassionate communications and policies on whether or not they will, or will not, grant access to life-saving drugs. For best practices for compassionate use communications, check out our own Paul Tyahla’s POV in PM360.
► CIGNA GOES THROUGH OXYCONTIN WITHDRAWAL
File this under: stories that are starting to sound very familiar. In a new round of corporate commitments in response to the opioid epidemic, Cigna announced this week that it won’t cover OxyContin prescriptions beginning in 2018. Just last month, CVS announced new limitations for the amount and strength of opioid painkillers it provides to new patients. Also this week, the Senate Committee on Health, Education, Labor & Pensions held a hearing on the federal response to the opioid crisis.
► OUR TAKE
How do we feel after this newest wave of opioid news? Kind of how Senator Murphy (D-CT) looked in the hearing:
Don’t get us wrong – it is critical to identify ways that the government, pharmaceutical companies and insurers can combat the opioid epidemic while still ensuring effective options for people living in pain. But it can feel difficult to discern between public pledges and meaningful (and effective) commitments to change. Critics are already poking holes in the above mentioned moves, relegating them to “PR stunts.” Our advice? Companies that want or need to take a stance on the opioid issue should make sure it’s backed up by proof points of past actions or realistic next steps. Our two cents: instead of one-dimensional pledges, lets’ focus on more comprehensive policies addressing appropriate prescribing, affordable access to non-opioid pain therapies, abuse deterrence and better addiction care.
Until next week,
The Reputation & Risk Management Practice