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Category Archives: Regulation

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House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of

CJEU upholds principle of free movement of goods for food supplements

The Court of Justice of the European Union (“CJEU“) has issued a ruling on the interpretation of Directive 2002/46/EC on food supplements, finding that a French law prohibiting the sale of food supplements from other EU Member States containing vitamins and minerals above French national limits is contrary to EU law. The CJEU held that

New EASA Consultation: Are Drone Pilots Heading for a Period of Regulatory Turbulence?

On 12 May 2017 the European Aviation Safety Agency (“EASA”) opened a consultation regarding sweeping new regulations on the operation of unmanned aircraft systems (“UAS” or drones) in European airspace. Individuals and companies that are interested in the future of UAS operations in the European Union (“EU”) should carefully review the Notice of Proposed Amendment and consider participating in the review process by submitting comments and letting EASA know their views on all aspects of the proposed regulations.
Under current regulations, EASA only regulates large UAS with a take-off weight of 150kg or more and the regulation of UAS weighting less than 150 kg is reserved to Member States. The European Commission and European Parliament are currently trying to extend the EU’s regulatory competences (jurisdiction) to include authority over all UAS weighing more than 250g. EASA’s new proposal will likely spur debate among industry stakeholders over whether this new and innovative technology should be regulated more broadly by EASA or by the individual Member States.

TCPA for the Boardroom – An Executive Focus

How do you protect your business from costly Telephone Consumer Protection Act (TCPA) lawsuits and regulatory enforcement actions? In this webinar, we will focus on the key decisions facing company executives as they navigate TCPA risks and assess compliance strategies. Businesses must stay in touch with their customers and their partners in order to succeed. But

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines. Public quality standards form part of the regulatory framework governing the quality of all medicines. Both documentary and physical standards exist to ensure that medicines are of acceptable quality for use by

Scottish government to reform approval process for new end-of-life and orphan medicines

The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report on 14 December 2016. The recommendations aim to further improve the process by which these types of medicines, in particular ultra-orphan products,

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug,

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.”  This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order

Don’t Blink: 9th Circuit Issues Pivotal Decision on Enforcement of CSA Against Cannabis-ness

As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I.  As marijuana remains a Schedule I controlled substance under the federal Controlled Substances Act (CSA), marijuana businesses operating in compliance with state law, and those who contract with such businesses, continue to

Certain Antiseptic Ingredients No Longer GRAS/GRAE, Says FDA

FDA announced a final rule today determining that certain common ingredients, most notably triclosan and triclocarban, in over-the-counter consumer antiseptic washes are not generally recognized as safe and effective (GRAS/GRAE), and thus, can no longer be provisionally marketed under the OTC Drug Review. The final rule affects the status of antibacterial soaps, hand washes, and

FDA Revises Its Drug Establishment Registration, Drug Listing, and National Drug Code (NDC) Regulations

Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule amending its regulations governing drug establishment registration and listing requirements for U.S. and foreign firms.  Also noteworthy is that the final rule expands FDA’s regulations governing National Drug Codes (NDCs).  The final rule is available at 81 Fed. Reg. 60170 (Aug. 31, 2016)

MHRA Publishes Draft Guidance on GxP Data Integrity

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published for public consultation a draft guidance on GxP Data Integrity which includes definitions of key terms. The draft Guidance applies to both paper and electronic data in all areas of GxP (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and

New Guidance Makes Clear that FDA Is Focused on Insanitary Conditions at Pharmacy Compounders

Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state

New Bill on Telemedicine is Submitted to the Russian Parliament

On 30 May 2016 a bill on telemedicine (the “Bill“) was submitted to the lower house of the Russian Parliament for consideration introducing a new form of provision of medical services in Russia – telemedicine (Bill No. 1085466-6 “On Introducing Amendments to the Federal Law “On the Fundamentals of Public Health Protection in the Russian Federation”

Court of Appeals Upholds FCC’s Open Internet Order

In a major victory for the Federal Communications Commission’s democratic majority, the U.S. Court of Appeals for the D.C. Circuit upheld the FCC’s 2015 Open Internet Order on June 14, 2016.  The 2-1 decision by the D.C. Circuit Court of Appeals likely is not the last word on net neutrality because broadband service providers will

Quiet Down? US Examines Whether Too Much Noise from Modern-Day Products Might Pose a Risk to Wireless Communications

The Federal Communications Commission (“FCC”) is seeking updated information on how the increased adoption of radiofrequency energy-emitting devices is affecting the level of unwanted RF energy emitted from man-made sources (the “spectrum noise floor”).[1]  The FCC’s Technological Advisory Council (“TAC”) has launched a technical inquiry to study changes to the spectrum noise floor over the

De-Regulating the Sharing Economy: European Commission Publishes Guidelines to Promote National Harmonization

Back in October 2015, as part of its Single Market Strategy, the European Commission declared that it would develop an agenda to encourage consumers, businesses and public authorities to engage confidently in the sharing economy (also known as the “collaborative economy”), where private individuals provide on-demand services to other people, without intermediaries. This peer-to-peer model

Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug

On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff’s emergency motion for a temporary restraining order against FDA, thereby preventing FDA from putting a clinical drug trial on hold with respect to the plaintiff, Eugene “Neil” Fachon. Fachon, a 20-year old student

Big News: Small UAS Rule at OIRA for Final Review

In a major new development, the FAA has sent the Small UAS NPRM to the White House for a final interagency review.  This means that a final small UAS rule is coming soon – and that NOW is the last opportunity to influence the rule before it is released. Before any significant regulatory action takes

FDA Issues Data Integrity Guidance, Providing Views on Expected Data Integrity Controls and Oversight

Earlier today, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing a topic affecting the entire pharmaceutical industry—Data Integrity.  The guidance, entitled Data Integrity and Compliance with CGMP, Guidance for Industry (Draft Guidance), and styled as a series of questions and answers, is the first guidance document FDA has issued specifically concentrating