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Day Two at AAM Annual Meeting – The Big Guns Come out

Day Two started with a recap of Day One (see post from yesterday here) by Dr. Nancy Snyderman.

Day Two kicked off with a session entitled Generics Help Patients, How Can Patients Help Generics.  This centered on digital virtual prescribing, digital physician visits, and what’s going on in that space.  The panelists described the impact of digital doctor visits and the impact on getting health care to the underserved even on mobile devices.  There is the ability to load the health care providers visits directly into the payment system and even the ability to get the treatment in the form of a prescription directly delivered to the patient.  Imagine the additional revenue that the drug industry could realize through tapping into such a system and being able to access the underserved patient population.  Telehealth care has become big business and extending that to underserved populations at a fraction of the cost of traditional medicine would thus be beneficial to both patients and drug manufacturers.

Telehealth care could be viewed as a cost-cutting measure, especially if it can capitalize on the lower cost of service delivery.  No brick and mortar, no travel time to the doctor, lower overhead – all you need is digital access.  It could, according to panelists, also translate into lower deductibles for patients.

The second panel of the day dealt with drug pricing, the opioid crisis, and the implications of the concept of the opioid tax some states are pushing.  The group cautioned against overreaction to the opioid crisis since most of the deaths from overdose are coming from illegal drugs, like fentanyl and heroin.  The consensus was that there needed to be a rational approach to the opioid problem that takes into consideration and places patients in intractable pain in focus.  A discussion of the failed Maryland price control legislative initiative also got some big airtime.  Panelists pointed out that the law, which targeted generic drug prices, was really misplaced since generic drug prices have been in a period of deflation over the last few years and generic drugs save consumers money over their brand name counterparts.  One of the panelists agreed that it was really brand name products that are the real cost problem and noted that Maryland is crafting a bill to deal with the brand side of the industry.

As the AAM conference goers anxiously awaited the remarks of Alex Azar, Secretary of the Department of Health and Human Services, the tension in the room built.  Dr. Azar did not disappoint, delivering an on-point assessment of the benefit of generics and the “shenanigans” that brand name companies were playing to maintain their monopoly markets.  Here are some of the important points Dr. Azar addressed:

  • The successful cost reductions and savings in the health care system that generics bring to the table
  • Discussion of the President’s blueprint for health policy and the important place that generics play in its implementation
  • The right incentives need to be in place in the payment system that can enhance and promote competition without raising prices
  • The importance of not only the safety and effectiveness of generic drugs but their access to patients
  • The FDA’s record-breaking number of ANDA approvals in FY 2017 and FY 2018, which translates to increased competition
  • Noted that rules need to be enforced to keep brand name players from gaming the system by use of a REMS program and restricted distribution systems to keep samples out of the hands of generics manufacturers that they need to conduct required regulatory studies necessary for ANDA filings
  • Overhaul of the Orange Book to contain more up-to-date information on reference-listed drugs and better identify those drugs that are currently being marketed and those that have been discontinued from marketing
  • Increase of resources to assist in development of guidance for complex generic products
  • Biologics represent 40% of the pharmaceutical spend; therefore, it is essential to develop FDA‑designated interchangeable biosimilar products
  • Education of the health care community about the benefits of biosimilars and identify the misrepresentations that are being made by brand manufacturers to the detriment of biosimilar uptake
  • Looking at importation of high-cost or shortage drugs and harmonization of U.S. and EU regulatory requirements
  • Increasing the use of generics in the Medicare Part D prescription program, which could save the government an estimated $3 billion and save Medicare beneficiaries approximately $1 billion in out-of-pocket expenditures
  • Overhaul of the drug rebate system that often causes patients to pay for brand-name products when a generic is available due to “backdoor rebates” that lock up drug contracts with insurance companies and prevent them from paying for generics.

His speech was credible, full of undisputed facts and statistics, and, with the exception of the issue of importation of foreign drug products, had the audience applauding after each of his major points.  He is a great speaker and, in my humble opinion, he and Dr. Scott Gottlieb, the FDA commissioner, are the brightest spots in the current administration.  Sorry about the length of the post but there was a lot of good stuff on Day Two!