Header graphic for print
Focus on Regulation

Category Archives: Regulatory

Subscribe to Regulatory RSS Feed

FDA aims to harmonize its human subject protection regulations with Common Rule

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January

Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

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

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling.  Under the 24-page decree, a federal court enjoined the defendants,

CMS proposes requiring drug prices in TV ads

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

The FDA now offers cGMP Declarations

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, introduced a new online application. The online application makes it possible to request a cGMP Declaration (Current Good Manufacturing Practice). A cGMP Declaration can be issued by the FDA to a foreign regulator, such as the competent

VA and SBA Release Complementary Final Rules Updating their Veteran-Owned Small Business Regulations

On September 24, 2018 and September 28, 2018, the Department of Veterans Affairs (VA) and the Small Business Administration (SBA), respectively, released complementary final rules (VA final rule and SBA final rule) that amend the regulations governing Veteran-Owned Small Businesses (VOSBs) and Service-Disabled Veteran-Owned Small Businesses (SDVOSBs). Effective October 1, 2018, the SBA’s regulations now

For Now, DoD Halts Efforts to Change Policy on Progress Payments

Deputy Secretary of Defense Patrick Shanahan announced on Monday, October 1, 2018, that the U.S. Department of Defense (“Department” or “DoD”) was withdrawing its proposal that would have made sweeping changes to the rules that govern the release of progress payments to contractors under DoD contracts. In rescinding the proposed rule, Deputy Secretary Shanahan cited

No-deal Brexit: New guidance on producing and labelling food products

In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019. Producing and labelling food Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”,

No-deal Brexit: Technical notices on trading goods published

The UK Government has released a further batch of technical notices, providing guidance to businesses on the implications of an exit from the EU without a Withdrawal Agreement on 29 Mach 2019. Three of these notices will be of particular interest to businesses trading goods in other EU Member States: 1. Trading under the mutual

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections.  According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

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

UK Government publishes first no-deal Brexit notices for food

The Government has released its first batch of technical notices which aim to prepare UK citizens and businesses for an exit from the EU without a Withdrawal Agreement on 29 March 2019. Of most relevance to food businesses are the notices on developing genetically modified organisms (“GMOs“) and producing and processing organic foods. Under the

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription.  The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing

Legislative and Regulatory Update on Federal Supply Chain Risk Management

The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. To achieve these goals, Congress and agencies have introduced, and in some cases enacted, legislation and regulations that direct agencies to identify, assess, and mitigate supply chain risks generally as well as prohibit agencies

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell Treatment Center, alleging the treatments seriously harmed patients. Both lawsuits follow up on prior actions that FDA initiated against these

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health. The Sunshine Act provides that life sciences companies must publically disclose information concerning all pecuniary advantages or benefits in kind granted, directly or indirectly from Belgium or elsewhere,

UK unveils reforms to give consumers a better deal

The UK government has published a Green Paper on Modernising Consumer Markets (the “Green Paper”). The Green Paper addresses the need to review the UK’s regulatory regime in light of the changing nature of consumer markets and practices to ensure that consumers are able to benefit from the development of new technologies and get the

“New Deal for Consumers” – draft package adopted by the European Commission

The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market. The package was adopted by the Commission in response to an evaluation on EU consumer protection and marketing directives. The evaluation found such laws need to be better applied, enforced

Rules of Origin: a ‘hidden hard Brexit’ for the UK food industry?

The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit. Rules of origin are the detailed content requirements that determine whether goods are

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and

One step closer to new rules on organic farming

After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonise the rules for organic food production and the labelling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the