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Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar spent on products ranging from heart valves to insulin to breakfast cereal, so there’s always something Congress can do in the realm of FDA’s statutory authorities. Many FDA-related bills are often bipartisan, too, which suggests action regardless of which party is in power. Here are a few key medical product issues we’ll be tracking in 2019.
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On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable.
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On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which are already posted on the Office of Information and Regulatory Affairs (OIRA) dashboard. The bulk of the rules on the Agency Rule List for Fall are under the purview of CMS or the FDA (63 and 77 rules, respectively). Also, earlier in October, FDA’s device center released a list of draft and final guidance documents it plans to publish in FY 2019. Many of these rules or guidance documents touch on issues top of mind and we expect that the administration will be moving forward with many of these priorities in the coming months. 
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On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing medical device software with adequate cybersecurity controls.  Once finalized, the draft guidance will supersede a final guidance of the same name issued in 2014.
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Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog series about AI in health care, explores FDA’s proposed regulatory model that is supposed to be better suited for AI (and similar technologies) while still protecting patients.
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In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps to ensure that quantitative efficacy or risk information does not convey inaccurate information and does not have the potential to confuse consumers. The draft guidance defines quantitative efficacy and risk information as “information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks.” FDA’s advice on how to most clearly share this type of information should be considered by companies when developing any form of DTC promotional media, whether they are digital, broadcast, in traditional print format, or otherwise.
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Congress has left town until after the midterm elections, but the Administration is continuing to advance its priorities in the regulatory arena. This week, the Administration is expected to publish the proposed rule, "Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency." We cover this and the political implications in this week's health care preview.
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Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the absence of coordination between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Still, companies must understand and appreciate the impact regulatory submissions may have on their patent portfolio.
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Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in the FDA’s Digital Health Innovation Action Plan. Others have been less trumpeted but are still significant developments for device manufacturers.
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.
As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.”
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S.
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018.
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process.
This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week.
Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a roller coaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago.
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance.
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
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