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February 15, 2019

5 Actions Taken Since the Release of Trump's Drug Pricing Blueprint

Samantha DiGrande
It’s been more than 100 days since President Trump and HHS Secretary Alex Azar announced the “American Patients First” drug pricing blueprint. Here are 5 actions the government has taken since its release.
It’s been more than 100 days since President Trump and HHS Secretary Alex Azar announced the “American Patients First” drug pricing blueprint. Here are 5 actions the government has taken since its release.

1. The FDA approved more generic drugs in July 2018 than any month in history

According to the report, “Report on 100 Days of Action on the American Patient [sic] First Blueprint,” released by the Trump administration last week, the FDA approved more generic drugs last month than in “any single month in its history.” In addition, the FDA also recently approved the first generic version of EpiPen under a new regulatory pathway designed to speed up the development and review of generic drugs that lack competition in the marketplace.

2. CMS announced new policy on step therapy

CMS recently announced that it will allow Medicare Advantage plans to negotiate drug prices for Part B drugs by allowing the plans to employ a utilization management strategy known as step therapy to newly diagnosed patients. The policy proposal has received pushback from some advocacy organizations that believe that step therapy can be detrimental to their patients’ health and quality of life.

3. The FDA approved 3 biosimilars 

Since the release of the blueprint, the FDA has approved 3 new biosimilars, Fulphila, Retacrit, and Nivestym. Additionally, the FDA also unveiled the long-awaited Biosimilar Action Plan, meant to spur biosimilar competition in the marketplace and encourage more biosimilar uptake. Notably, the report released by the administration on the progress made in the past 100 days incorrectly stated that there are only 10 biosimilars approved (there are 12), as well as mentioning only 1 biosimilar approval in this time period.

4. Big pharma pressed pause on price hikes 

Major pharmaceutical companies such as Merck, Novartis, and Pfizer announced that they would not increase drug prices for the remainder of 2018. However, these announcements have come largely after companies have already instituted their annual price increases, making certain analysts wonder if patients will actually feel savings from these price freezes. Additionally, some specific drugs that companies have put on a “price freeze,” or drugs in cases where they have even decreased the price of a product, have accounted for a minimal fraction of the company’s total sales.

5. The FDA created a working group to consider prescription drug importation

HHS Secretary Alex Azar requested that the FDA establish a working group to examine how to safely import prescription drugs from other countries in an effort to address price hikes of drugs produced by a single manufacturer with no competitor product on the market. Although similar ideas have traditionally been struck down by previous administrations, Azar believes there are certain situations in which importation could make sense, citing the example of the 5000% price hike on the drug Daraprim in 2015 that made then-CEO Martin Shkreli a household name.

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