With the deadline for the reauthorization of the Medical Device User Fee Amendments (MDUFA) looming in September, many observers expect that the push for reform in the regulation of in vitro diagnostic (IVD) tests may soon be coming to a head on Capitol Hill. At its core, the debate boils down to whether regulatory oversight [...] Read More
The Food and Drug Administration (FDA) has released their long-awaited proposed rule on prescription drug importation. President Trump has mentioned his plan at events in recent months, citing the plan as part of the administration’s efforts to lower prescription drug costs. The proposed rule outlines requirements for so-called Section 804 Importation Programs (SIPs), named after [...] Read More
Smart phones, social networks and internet applications help us communicate with family, friends and colleagues, but they can do so much more to improve our lives. Advances in technology and connectivity offer new methods for monitoring and accessing information about our health and well-being. Earlier this year, CMS Administrator Seema Verma announced that the Centers [...] Read More
On February 9, 2018, the Council of Economic Advisers released a report looking at drug pricing proposals entitled “Reforming Biopharmaceutical Pricing at Home and Abroad.” The report highlights two goals: reducing the price that Americans pay for biopharmaceutical products and raising innovation incentives as a way to reduce the overall price of health in the […]
Read MoreOn July 18, 2017, the Food and Drug Administration (FDA) hosted a public meeting entitled, “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The meeting was a public opportunity for interested stakeholders to provide the FDA with information and policy recommendations about how to encourage competition while also maintaining access. Much of the […]
Read MoreThe Office of the Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) has released their Fiscal Year 2017 HHS OIG Work Plan. The OIG seeks to identify opportunities to improve various HHS programs and also holds those who do not meet requirements or violate federal laws accountable. Their work encompasses […]
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