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Focus on Regulation

Congress Invalidates Controversial Fair Pay and Safe Workplaces Regulations

*Associates Ryan Harrigan and Ogechi Achuko also contributed to this post

Earlier this week, on March 6, 2017, the Senate passed a joint resolution disapproving the Fair Pay and Safe Workplaces Final Rule (the “Rule”), which mandated contractor reporting of labor law violations, and had earned the title of the “blacklisting” rule—as those disclosures could negatively impact a company’s ability to obtain U.S. government contracts.  H.R.J. Res. 37, 115th Cong. (2016).  The joint resolution was passed by the House of Representatives in early February, and now awaits President Trump’s signature, which would invalidate the Rule entirely. Continue Reading

Brexit: the ball is in which court?

The UK Government’s Brexit white paper asserted that Brexit will end the jurisdiction of the CJEU (Court of Justice of the European Union) in the UK. However, the reality is more complex. We explain why the CJEU’s significance cannot be ignored. Read the full blog here.

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition for pharmaceutical manufacturing inspections.  The amended agreement will allow FDA and EU regulators to rely upon information from drug inspections conducted within each other’s borders.  According to FDA, over the last 5 years, about 40 percent of FDA’s drug inspections were performed in the EU.  Although FDA inspections in the EU are sure to continue, this agreement now allows FDA to shift even more inspections to China, India, and Asia more broadly, where drug manufacturing has greatly increased along with FDA’s enforcement focus.

Seeking to Restrict Chinese Investment in the U.S., Congress Considering CFIUS Reforms

Lawmakers in both the U.S. House of Representatives and Senate are examining ways to restrict Chinese investment in the United States by reforming national security reviews conducted by the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee. The prospects for statutory changes to CFIUS reviews appear greater now than at any time since the underlying statute was overhauled nearly a decade ago. Continue Reading

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH), the FDA center that governs medical devices, reached an 8 year low, down 50% from FY 2015. The drop in CDRH issued warning letters coincided with a significant rise in the number of warning letters issued by the Center for Drug Evaluation and Research (CDER), which more than doubled from FY 2015. This is the first time in at least 8 years that the number of annual (FY) warning letters issued by CDER exceeded the number issued by CDRH. It is interesting to note that the number of 483 observations issued for devices remained much higher than for drugs, despite many more warning letters being issued for drugs compared to devices. Continue Reading

Outlook for Disgorgement Remedies in the Trump Administration

720px-US-FederalTradeCommission-Seal.svgWith the departure of now former Chairwoman Edith Ramirez earlier this month, among the most discussed vacancies in the new administration these days is the post of permanent Chair of the Federal Trade Commission. According to reports, one leading candidates is Acting Chairman Maureen Ohlhausen, and her selection could also have significant implications for FTC policy areas—particularly with respect to disgorgement remedies in antitrust cases. Specifically, should she become the permanent Chairman, Acting Chairman Ohlhausen’s record and recent comments indicate a potential shift away from disgorgement as a remedy in FTC cases.

Read more here.

What’s in store for the Affordable Care Act and drug pricing policy under the Trump administration?

The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled Congress to begin rolling back key provisions of the legislation. The promised repeal and replacement of the ACA has effectively left insurers in a holding pattern. It has also created a period of extraordinary uncertainty for the Centers for Medicare & Medicaid Services (CMS) and the healthcare stakeholders that it regulates. Ken Choe and Beth Roberts, partners in the health group at Hogan Lovells, say that the changes being considered would have profound impact across the healthcare landscape, and may also impact drug pricing in the US. Continue Reading

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are out

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”). The finalised versions of the draft texts are available here and here.

Final Adoption of the texts anticipated in March

The Council of the European Union is expected to hold a vote to adopt the MDR and the IVDR on 7 March 2017. This will be followed by a vote by the European Parliament on 20 March 2017.

If the above timeline for adoption is respected, the adopted MDR and IVDR texts could be published by May 2017 and enter into force in May or June 2017. In these circumstances, the MDR would be applicable by 2020 and the IVDR by 2022.

The two Regulations will replace the current Medical Devices Directive1, the Active Implantable Medical Devices Directive2 and the In Vitro Diagnostic Medical Devices Directive3. This will result in a substantial revision of the current regulation of medical devices and in vitro diagnostic medical devices in the EU.

New transitional provisions

The two Regulations include transitional provisions permitting CE Certificates of Conformity issued by notified bodies in accordance with the current Directives, and prior to the date of the entry into force of the MDR and IVDR, to remain valid until the end of the period indicated on the certificates.

There are, however, related limitations. The medical devices to which these Certificates relate may be placed on the EU market or put into service in the EU only if, from the date of application of the relevant Regulation, they continue to comply with the relevant current Directives, and provided there are no significant changes in the design and intended purpose of the medical devices. Moreover, there will be related changes in some obligations related to the devices. The requirements of the relevant Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

We will provide more detailed information and analysis concerning the changes that the new Regulations will introduce in future blogs.

 

1 – Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

2 – Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

3 – Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

U.S. Departments of Education and Justice Withdraw Guidance on Transgender Students

On February 22, the U.S. Departments of Education and Justice (“ED” and “DOJ,” respectively, and collectively, the “Departments”) issued a two-page Dear Colleague Letter to “withdraw and rescind” policy and guidance reflected in two documents issued by the Obama Administration. Those guidance documents interpreted Title IX of the Education Amendments of 1972 (“Title IX”) and its implementing regulations, which prohibit sex discrimination in educational programs and activities operated by recipients of Federal financial assistance, to prohibit discrimination based on a student’s gender identity, including discrimination based on a student’s transgender status. In the new Dear Colleague Letter, the Departments explain that they have decided to withdraw and rescind the guidance documents “in order to further and more completely consider the legal issues involved” in the interpretation of Title IX, and they “will not rely on the views expressed” within the previous guidance documents. Among the points made to support the action, the Departments express a belief that “in this context, there must be due regard for the primary role of the States and local school districts in establishing educational policy.” The Departments note that the withdrawal of the guidance documents “does not leave students without protections from discrimination, bullying, or harassment.” Although the new Dear Colleague Letter appears to have been written with public school districts particularly in mind, the withdrawn guidance had expressed positions with regard to universities and colleges as well.

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