On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market. Although the draft guidance doesn’t break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply. Citing
FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the greatest benefit to patients and providers, and (perhaps in particular) generic drug developers. The Commissioner’s announcement addresses several important issues, including patent listing standards
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some functions shut down, as was announced yesterday. Among other things, FDA has furloughed 42% of its employees, according
Earlier today, FDA published its finalized Data Integrity Guidance. The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency’s April 2016 Draft Guidance covering the design, operation, and monitoring of systems and controls to maintain data integrity to comply with current good manufacturing practice (cGMP) for
With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies.
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval inspections. The protocols were developed through the agency’s New Inspection Protocol Project (the “NIPP”), initially launched in 2014. The NIPP is intended to
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law 115-92, which was enacted in 2017. The law gives the DoD new opportunities to advocate to FDA for expedited development,
On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims. In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell
President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on an “International Pricing Index” (IPI), under which U.S. drug prices would be benchmarked against 16 other countries that reportedly have lower drug prices. This
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would
Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices
One day after the Venezuelan government held elections for a Constituent Assembly that the United States has asserted is aimed at rewriting the national constitution, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) designated the President of Venezuela, Nicolas Maduro.
Ahead of a Constituent Assembly that could re-write the Venezuelan Constitution and dissolve state institutions, the U.S. Treasury Department’s Office of Foreign Assets Control has designated 13 current and former Venezuelan government officials.
Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews, continue apace. This week saw the introduction of bipartisan legislation in the U.S. Senate that would (i) give federal agriculture and food officials permanent representation on CFIUS and (ii) amend the statute to allow the Committee to consider agriculture and food-related criteria when reviewing transactions that could result in control of a U.S. business by a foreign person.
The future of the Border Adjustment Tax (BAT) proposal, a critical element of the House Republican tax reform plan, is in doubt after signs of Republican opposition in the Senate emerged last week. Senator David Perdue (R-GA) became the most prominent Republican to overtly criticize the BAT, expressed in a Dear Colleague letter to his
The U.S. House and Senate have released their legislative calendars for the second session of the 115th Congress. Hogan Lovells’ Government Relations and Policy Advocacy practice is happy to provide you with this congressional calendar for your 2017 planning purposes.
The last three days since the election has seen a frenzy of activity as the expanding team of President-elect Donald Trump has begun the process of forming the players and agenda of the Trump Administration.
After the UK Brexit referendum of 23 June the implications on the political, economic and legal relations between the UK and the EU have been discussed from many angles. But what about one of the main pillars for the successful integration of the European Single Market: State aid law? Does the end of EU membership
The U.S. House and Senate have released their legislative calendars for the second session of the 114th Congress.
Austin, Texas is renowned for its live music scene, clean air, college vibe … and of course its technology conferences. Two Hogan Lovells Lawyers—Bret Cohen and Lisa Ellman—have made the list of finalists for panels at the South by Southwest group of conferences this upcoming March, to talk about Student Privacy and Domestic Drone Policy.
In a first-of-its-kind ruling and a significant victory for state wildlife agencies, landowners, ranchers, farmers, and the oil and gas industry in Texas, New Mexico, Oklahoma, Kansas, and Colorado, the U.S. District Court for the Western District of Texas, in Permian Basin Petroleum Association (PBPA) et al. v. Department of the Interior (DOI), et al.,
The independence of the judiciary and the separation of powers are fundamental principles of constitutional government intended to ensure that the proper functioning of each of the separate branches of state (the executive, legislature and the judiciary) acts as a check and balance against the exercise of power by the other branches. How this doctrine
In a very recent judgment, the First-Tier Tribunal Tax Chamber considered an interesting argument raised by a taxpayer that a penalty issued by HMRC was contrary to the provisions of the 1688 Bill of Rights and therefore invalid. In Pendle v the Commissioners for Her Majesty’s Revenue & Customs  UKFTT 27, Mr Pendle appealed
After failing to pass a TRIA reauthorization during the lame duck session last Congress, on January 7, 2015, the House passed H.R. 26, the Terrorism Risk Insurance Program Reauthorization Act of 2015, by a vote of 416-5. Shortly after on January 8, 2015, the Senate passed H.R. 26 by a 93-4 vote. Upon the President’s signature, TRIA will be reauthorized until December 31, 2020.