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Focus on Regulation

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 their products that are not described in their labeling.  This hearing represents the latest development in the recent flurry of activity surrounding the U.S. Food and Drug Administration’s regulation of manufacturer communications related to unapproved uses of their products since FDA’s issuance of two draft guidances and a First Amendment memorandum right before the change in administration earlier this year.

The first bill seeks to limit the definition of intended use of drugs and devices by amending FDCA Section 201A to prevent the intended use of a drug or device from being determined by reference to (1) actual or constructive knowledge that the product will be used “off-label” in a manner that differs from the use for which it is cleared, approved, or licensed; (2) non-public manufacturer statements about the product that are not included in any promotional materials or statements to third parties; or (3) communications considered to be scientific exchange.  The proposed bill also would add a scientific exchange “safe harbor” for dissemination of off-label information about a drug or device.

The second bill seeks to amend the definition of false or misleading labeling by amending FDCA Section 502(a), which allows for provision of certain health care economic information to entities making coverage decisions, to explicitly include devices, as well as drugs.  It also includes a new paragraph exempting the provision of such information to these entities from the misbranding provisions of the act if the information is based “on competent and reliable scientific evidence and relates to an investigational use of a drug or device.”  The proposed language goes on to define specific criteria for when information related to an investigational use of an approved, cleared, or licensed drug or device may be provided.

Interested parties can attend the hearing in person in room 2322 of the Rayburn House Office Building or via webcast, which will be available at http://energycommerce.house.gov/.

Ministers Provide Insight on the UK’s Position on the Regulation of Medicines post-Brexit

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears from a recent letter to the Financial Times (FT) that Government ministers are listening.

On 3 July 2017, the UK ministers for Health and Business, Jeremy Hunt and Greg Clark, wrote an open letter to the FT seeking to provide reassurance that the UK intends to seek close collaboration with the EU in relation to the regulation of medicines post-Brexit.

The letter sets out three principles for the development of the UK medicines regulatory system post-Brexit: patients should not be disadvantaged; innovators should be able to get their products into the UK market as quickly and simply as possible; and the UK should continue to play a leading role in promoting public health.

The letter also states that patient safety will be at the heart of the new regulatory system and recognises the positive impacts that close UK/EU collaboration and data sharing has had to date in areas such as product development for rare diseases. The ministers also emphasise the need to support medical research and scientific collaborations across Europe, as well as ensuring that the UK continues to play a leading role in medical innovation and promotion of public health, with support from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and by working closely with the European Medicines Agency (EMA) and other international partners.

The ministers specifically state that under the post-Brexit regime, UK licences will be processed as quickly as possible and fees for doing so will be competitive. The majority of new, innovative medicines in the EU are currently authorised by the EMA and depending on the outcome of negotiations, companies may be required to apply for authorisation both in the EU and the UK in order to access the two markets. Establishing a quick and easy procedure in the UK will therefore be key in continuing to attract companies to obtain marketing authorisations for new medicines for the UK market.

The letter concludes that the UK is open to a “deep and special” relationship with the EU and that this is the best way to promote improved patient outcomes both in Europe and globally.

The Minister’s letter is the clearest indication to date that the UK Government envisages that, post-Brexit, the UK will have a separate medicines regulatory system from the EU, but that it should be closely aligned with the EU system. The emphasis in the letter on protecting patient’s interests and supporting the UK life sciences industry should help to reassure patients and industry that the Government is taking on board their concerns and that the regulation of medicines, and the life sciences industry more generally, are high on the Brexit agenda.

The EU Commission has also begun to publish its negotiating position on a number of issues. The Commission’s approach to continued collaboration with the UK is less clear. On the one hand, in one of its recent Brexit negotiating position papers (on Goods placed on the Market under Union law before the withdrawal date), the Commission stated that products lawfully placed on the market before Brexit should be permitted to remain in circulation, and the withdrawal agreement with the UK should establish mechanisms for the exchange of information and cooperation on market surveillance for such products. However, the paper also states that EU risk assessments, approvals and authorisations for medicinal products (and other products) currently being led by a UK authority (being the MHRA in the case of medicinal products) should be transferred to another national competent authority post-Brexit “where appropriate”. The European Medicines Agency (EMA) has also published its own Brexit Q&A for marketing authorisation holders of centrally authorised medicines. You can read more about this here. Further details of the EU’s position for the life sciences sector specifically have not yet been published.

New UK Brexit Health Alliance Formed

A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include NHS organisations, industry associations, universities, research organisations and charities, the Royal Colleges, such as NHS Confederation, NHS Providers, the Association of the British Pharmaceutical Industry (ABPI), the Association of British Healthcare Industries (ABHI) and the BioIndustry Association (BIA). The BHA will be co-chaired by Sir Hugh Taylor (the former permanent secretary at the UK’s Department of Health) and Niall Dickson (chief executive of the NHS Confederation).

The aim of the BHA is to achieve the best outcome for UK patients and healthcare in Brexit negotiations to assist the Government by ensuring that issues such as patient access to medicines and technologies, healthcare research funding and UK citizen’s rights to receive healthcare in EU countries are prioritised in the negotiations. The BHA believes that it is in both the EU’s and UK’s interests to maintain co-operation in the areas of public health and healthcare research.

The BHA has been formed in response to concerns about the implications of Brexit for the NHS, especially in relation to access to new technologies and the possible loss of thousands of EU nationals working in health and social care across the UK, as well as calls from industry groups such as the ABPI for the Government to ensure continued access to talent in the UK and for close regulatory alignment with the EU to facilitate frictionless trade between the regions.

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures (MAPP) outlining the Office’s policy goals, roles, and responsibilities with respect to financial disclosures in NDAs, BLAs and NDA/BLA supplements. These financial disclosures have been required under 21 CFR Part 54 since the final rule became effective in 1999.

Under 21 CFR Part 54, a sponsor of an NDA, BLA, or NDA/BLA supplement must disclose, for covered clinical studies, specified financial interests that clinical investigators have in the sponsoring company or in the product under development. Alternatively, the sponsor must certify to the absence of such financial interests. The purpose of these disclosures is to enable the agency to assess whether clinical investigators’ financial interests may have affected the reliability of clinical data included in an application. It has been relatively unclear, however, to what extent and how FDA has taken these financial disclosures into account when evaluating an application. Continue Reading

U.S. Supreme Court Forbids Exclusion of Churches from State Grant Program

On June 26, 2017, in Trinity Lutheran Church of Columbia, Inc. v. Comer, the U.S. Supreme Court held unconstitutional under the Free Exercise Clause Missouri’s refusal to award a playground resurfacing grant to a church.  The Court ruled for the first time that the government’s decision to exclude churches because of their religious identity from a generally available public grant program must survive strict scrutiny.  The Court also made clear that a state’s “policy preference for skating as far as possible” from the Establishment Clause cannot alone justify such discrimination. Continue Reading

“Friends forever? Joint and several liability for cartel damages”

“Good friends can never be separated; good friends are never alone; for there’s one thing in life they know how to do, be there for one another…”. This timeless classic was sung by Franz Beckenbauer on the occasion of the 1966 FIFA World Cup in England. And he is right: friends show consideration for each other and they are sincere to one another. As delightful as these virtues are for interpersonal relationships; as troublesome they are for intercorporate ones. If companies are too friendly with one another, they may breach antitrust law. Yet, what about friendship, when the cartel is over and third parties are eager to claim their cartel damages? Continue Reading

What applies as of when? – When will the 9th amendment of the German Act against Restraints of Competition (GWB) apply?

So it has begun. However, when will the new provisions of the 9th amendment of the GWB actually apply? Aside from a number of exceptions, the 9th amendment will come into force on the day following its promulgation. But, a number of not insignificant provisions will have retroactive effect. This sounds as if it could be exciting.

The legislature has determined a time of entry into force for the 9th amendment of the GWB pursuant to Article 82(2)(1) of the German Fundamental Law. According to that provision, certain provisions regarding cartel damages claims entered into force already as of 27 December 2016 (Article 8 S. 1 of the amendment). The other provisions entered into force on the day following the promulgation, i.e. on 9 June 2017. Beyond that, there are a number of questions as to when certain provisions will apply and whether transitional rules will apply in some cases.  The present contribution offers a short overview in this regard. Continue Reading

For the good of the consumer – consumer protection in the 9th amendment of the ARC

Provisions on consumer protection account for only a small part of the 9th amendment of the German Act Against Restraints of Competition (ARC), which recently came into force. However, the introduction of the reform has led to a highly controversial debate in the press and literature.

Consumer protection in Germany

Traditionally, private enforcement is the main means of protecting consumer rights in Germany. This involves consumers or, more probably, recognised consumer protection associations bringing private law actions to ensure that consumer protection provisions are applied. Unfair competition law plays a central role here. For example, consumer organisations issue cease and desist letters in response to breaches of general terms and conditions of business. If unsuccessful, they then take legal action.

Unlike previously, the debate about the 9th amendment of the ARC focused on strengthening public enforcement. Not that public enforcement of consumer protection law is completely unknown in Germany: the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht – BaFin) and the German Federal Network Agency (Bundesnetzagentur – BNetzA) already have powers to enforce consumer rights. BaFin is responsible for the protection of all consumers in the area of financial services, while the BNetzA monitors the misuse of phone numbers. As a result of the 9th amendment of the ARC, the German Federal Cartel Office (FCO) now also has powers to protect consumers. Continue Reading

Hogan Lovells Obtains Major TCPA Consent Revocation Victory

On June 22, 2017, in Reyes v. Lincoln Automotive Financial Services, the U.S. Court of Appeals for the Second Circuit agreed with Hogan Lovells attorneys representing the defendant and held that the Telephone Consumer Protection Act (“TCPA”) does not permit a consumer to revoke her consent to be called when that consent forms part of a bilateral contract.  The Second Circuit’s precedent-setting decision, if adopted by other courts, may have far-reaching implications for how companies draft their contracts and service agreements and structure their TCPA compliance approaches.

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Lost in the woods? Special treatment for the press, cooperative and savings bank associations and the timber industry in German Competition Act reform

Current legislative changes in the German Competition Act and the Federal Forest Act bring a set of new antitrust exemptions. We briefly present them in our blog:

1. Cooperation between press companies

Press companies can from now on cooperate more easily. Newspaper and magazine publishers (but not mere press distributors) are exempt from the German cartel prohibition in cases of economic, non-editorial cooperation if the cooperation allows them to strengthen their economic basis for intermedial competition. Effects cushioning competition on the press markets (intramedial) are thus tolerated to strengthen the press’s position in competition with other media (intermedial). As long as the cooperation does not affect editorial content, the privilege goes far; it includes, for instance, purchasing cooperation (e.g. for non-editorial services), production cooperation (e.g. for printing) and distribution cooperation (e.g. for subscriber acquisition, delivery or even coordination of resale prices). If the parties to cooperation can demonstrate a substantial legal and economic interest they are even – beyond the normal rules in competition law – entitled to a formal decision from the competition authority establishing a lack of need to intervene. European law remains however unaffected of all this. The privilege does therefore not apply if the cooperation has cross-border effects. This can be the case for cooperation on a federal level already, which is why the privilege may rather be a suitable basis for regional cooperation. Likewise, the prohibition of abuse of market power remains applicable. Continue Reading