HealthCommentary

Exploring Human Potential

15 Ways To Lower U.S. Drug Costs

  1. A role back on the various enabling legislative actions that provided multiple escape clauses for patent extensions. “Me-too” patents will be harder to come by. A new patent for simply flipping the chemical isomer of a compound? Less likely in the future.
  1. Enforced illegality of “pay-for-delay” subversion of market forces between branded and generic companies.
  1. More prominent state attorney general activity (as we saw with tobacco) when it comes to deceptive advertising, off label marketing, and anti-competitive behaviors. And a greater willingness, as with Martin Shkeli, to pursue criminal charges against a CEO.
  1. Regulators and legislators will soon call PhRMA’s bluff (and Lou Lasagna’s in the past) that a Wild West environment enhances innovation. Quite the opposite – it encourages fraud. True innovation occurs when honest and hard fought discoveries are able to enter markets uncluttered with weak facsimiles and fraudulently priced old standards.
  1. Elimination of DTC advertising – beneficial on two fronts. First, it would stop the practice (legal only in the US and New Zealand) of “creating a market and selling into it”. Second, dollars saved by the companies might appropriately be re-applied to honest research and development.
  1. Elimination of road blocks to proving generic bio-equivalency to branded drugs that have gone off patent. For example, companies would be forced to provide generic companies with product samples for testing once the product is off patent. At the same time, generic fast tracking would become a well-financed priority of the FDA by beefing up their Office of Generic Drugs.
  1. The FDA using its’ existing power to allow parallel imports of specific drugs from other countries when manufacturers attempt to deliberately obstruct distribution in support of non-competitive pricing. Do it once, and they’ll get the message.
  1. National standardization of generic substitution laws to remove remaining barriers. All states should allow generic substitution without physician or patient direction. If the FDA has codified a generic as the same as the branded variety, that’s quite enough. These continued unnecessary administrative and politically motivated road blocks cost Americans hundreds of millions of dollars with no benefit to show for it.
  1. Reciprocal recognition of generic products approved by the European Medicines Agency would open our markets, at no additional regulatory cost to taxpayers, to additional safe generic drug options not yet available in the US.
  1. Liberal support for the emergence of clinically equivalent follow-on biologic products, with appropriate post-marketing safety reinforced by access to modern consumer data bases.
  1. Institution of Medicare Part D government price negotiations while continuing to explore allowing Medicare and Medicaid formulary choice flexibility rather than cover 100% of FDA approved products; and exploration of incentive pricing to support the most efficient and effective products.
  1. Funding and publicizing comparative effectiveness studies from around the globe including pricing. Encourage broad consumer exposure through publications like Consumer Reports. Mandate open access to overseas products if excessive price or supply limits substantial American patient access to critical products.
  1. Use of the “march-in rights” originally written into the Bayh-Dole Act (which made federally controlled patents derived from discoveries emerging from NIH supported research available to commercial concerns) to open access to federal supplies of products deemed commercially “unavailable or unaffordable”.
  1. Making it easy for practicing physicians to know comparative pricing of drugs in their community through publicized accessible Apps and online databases.
  1. Employing “academic detailing” in all institutions associated with Medical Schools and residency training programs. Create monthly, mandatory attendance “Economic Grand Rounds” focused on cost and comparative effectiveness.

To access the original JAMA article from which this list is derived, go HERE.

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