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Focus on Regulation

Supreme Court Strikes Down Wartime Tolling of Civil Fraud Claims, While Affirming First-to-File Reinstatement for Civil False Claims Act Cases

Offering a mixed bag for federal contractors, on May 26, 2015, the Supreme Court of the United States unanimously overturned the Fourth Circuit’s decision in United States ex rel. Carter v. Halliburton Co., 710 F.3d 171 (4th Cir. 2013) that the Wartime Suspension of Limitations Act (WSLA) could be used to toll the statute of limitations on civil fraud claims.  At the same time, the Court affirmed the Fourth Circuit’s holding that the relator’s claims were not barred under the first-to-file doctrine where the prior claim had been dismissed for lack of prosecution.  Both holdings have significant implications for federal contractors and recipients of federal financial assistance. Continue Reading

U.S. FCC Chairman Circulates Proposed TCPA Decision with Significant Impact Across Industry Sectors

Today, FCC Chairman Wheeler announced that he is circulating a proposal to address more than twenty pending petitions seeking clarity regarding the scope requirements under the U.S. Telephone Consumer Protection Act (TCPA).  He authored a blog post on the proposal and also released a fact sheet.

As part of the Chairman’s proposal, the FCC would issue the following rulings:

  • Consumers can revoke their consent to receive automated “robocalls” and texts in any reasonable way at any time;
  • Carriers would be expressly allowed to offer robocall-blocking technology;
  • Callers would be prohibited from calling reassigned telephone numbers after one call;
  • The term “automatic telephone dialing system” in the TCPA would be interpreted to encompass any technology with the capacity to dial random or sequential numbers; and
  • Exceptions would be allowed in limited, specific circumstances for urgent communications, such as for bank account fraud and prescription refill reminders (the calls and texts must be free and consumers would still be able to opt-out).

The proposal is expected to be voted on at the FCC’s next open meeting on June 18.

How can we help?

Our TCPA Working Group brings together more than 25 attorneys in our litigation, communications, and privacy practice areas.  We provide regular TCPA counseling to clients from a broad range of industries, including technology, healthcare, communications, transportation, and financial services.  We have secured dismissals and nominal settlements for clients in TCPA actions and have worked with the FCC to clarify rules addressing a number of key TCPA issues.

The author wishes to thank Gregory Oshel in our Washington, D.C. office for his contribution to this article.

European Medicines Agency Fine-Tunes Guideline on Fixed Combination Medicinal Products

On 13 May 2015, the European Medicines Agency released for consultation the draft Guideline on the clinical development of fixed combination medicinal products. The draft Guideline is intended to replace the 2009 Guideline on clinical development of fixed combination medicinal products.

It is recalled that a fixed combination medicinal product contains two or more active substances within a single pharmaceutical form. The purpose of the draft guideline is to clarify several aspects of the 2009 Guideline. The legal basis on which a marketing authorisation application in relation to a fixed combination medicinal product can be submitted is addressed. The revised draft guideline is, however, confined to scientific requirements. Moreover, combination pack medicinal products are excluded from the scope of the document. From a regulatory perspective, combination packs are not considered to be the same as a fixed combination medicinal product.

Legal basis

The draft Guideline highlights that the choice of legal basis for submitting a marketing authorisation for a fixed combination medicinal product rests with the applicant. The scientific requirements governing clinical development of the product should be considered by the applicant, regardless of the chosen legal basis. Reference to Article 10(b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use, governing medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, is removed in the amended Guideline. The removal of this reference (which was provided in the 2009 Guideline) serves to suggest that Article 10(b) of Directive 2001/83/EC is not the sole legal basis for the submission of a marketing authorisation application.

Scientific aspects

The draft Guideline makes clear that the development of fixed combination medicinal products should be based on valid therapeutic indicators. The evidence base to be used to demonstrate that the benefit-risk is favourable towards the fixed combination product should take into account the following elements: (i) the clear identification of the patient population in need of a particular combination; (ii) the fixed combination is premised on valid therapeutic principles; and (iii) efficacy and safety is enhanced by the proposed fixed combination by contrast to each substance administered alone.

Existing clinical requirements which may be used to establish the evidence base for the therapeutic scenario necessitating a fixed dose combination have not changed. However, the new draft Guideline underlines that bioequivalence of the fixed combination medicinal product against mono-components taken simultaneously will be an added requirement.

Stakeholders have until 15 November 2015 to submit their comments on the scientific principles laid down in the document.

The General Court Rules on Access to Documents Communicated between the European Commission and a National Competent Authority

On 12 May 2015, the General Court of the European Union upheld a decision of the European Commission which denied access to documents exchanged during investigational proceedings with a national competent competition authority.

According to Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents a citizen may submit an application for access to documents held by the institutions of the European Union. The Regulation is intended to ensure the widest possible effect to the right of public access to documents, subject to the principles, conditions and limits outlined therein.

The judgment in Unión de Almacenistas de Hierros de España v. Commission (Case T-623/13) confirms that documents may not be subject to full access if disclosure could undermine (i) the protection of commercial interests and (ii) the purpose of investigations, as established by Article 4(2) of Regulation (EC) No 1049/2001 (the “Regulation”). Continue Reading

The Mexican Civil Aviation Authority Has Issued a New Mandatory Circular for all Remotely Piloted Aircraft Systems (RPAS) Operations

On April 8, 2015, the DGAC issued a new mandatory circular CO AV-23/10 R2 that “establishes the requirements to operate RPAS” to be more in line with the regulatory regimes of other countries that have developed such regulations.

Read More: The Mexican Civil Aviation Authority Has Issued a New Mandatory Circular for all Remotely Piloted Aircraft Systems (RPAS) Operations

U.S. Loses Appeal of WTO Ruling on COOL, Raising Risk of Retaliation Unless COOL Is Repealed

The WTO Appellate Body on May 18, 2015, publicly released a report upholding earlier findings that the United States has violated WTO rules in applying country of origin labeling (COOL) to beef, pork, and other meat products. This latest ruling may result in repeal of the U.S. COOL requirements.

Read More: U.S. Loses Appeal of WTO Ruling on COOL, Raising Risk of Retaliation Unless COOL Is Repealed

European Medicines Agency Launches Consultation on Good Pharmacovigilance Practices for Educational Materials

On 27 April 2015, the European Medicines Agency (“EMA”) launched a public consultation on its Good Pharmocoviligance Practices (“GVP”) concerning educational materials. The draft guidelines are contained in GVP Module XVI Addendum 1.

In accordance with GVP Module V on risk management systems, it is recalled that the marketing authorisation applicant/holder should provide details on the risk minimisation measures that should be taken in order to mitigate the safety concerns of the medicinal product. Additional measures should also be introduced when deemed necessary for the safety of the medicinal product. Educational material should be submitted to the competent authority of the EU Member State following the conclusion of the regulatory procedure in which approval of the risk minimisation measures has been attained. Continue Reading

Recent First Amendment Rumblings

Lately, there seems to be a palpable uptick in news related to FDA’s regulation of off-label communications.  Here are some of the developments we’ve been following:

In April: 

  • CDER Director Janet Woodcock noted in her remarks at the FDLI Annual Conference that the agency is “currently evaluating our advertising policies in light of first amendment issues … that is something we are doing very diligently right now.”
  • FDA Chief Counsel Elizabeth Dickinson announced that the agency will hold a public meeting this summer to address industry’s first amendment concerns about FDA’s restrictions on off-label promotion.
  • PhRMA published an article in the Food and Drug Law Journal calling on FDA to establish a “clear safe harbor” for manufacturers to share data and information with healthcare professionals about off-label, medically accepted uses of FDA-approved products.

Last week:

  • On May 6th, FDA announced it was withdrawing 47 draft guidance documents that were published before December 31, 2013 but never finalized.  This en masse withdrawal was part of a broader action plan to resolve a much larger number of draft guidance documents published before December 31, 2013.  This broader action plan noted that the 2011 draft guidance on responding to unsolicited requests for off-label information would be reissued, with a target date of 2Q 2015.
  • Yet the next day, trade press reported that FDA plans to delay issuance of the unsolicited requests guidance until after the public meeting this summer.
  • Also on May 7th, Amarin Pharmaceuticals, Inc. and four New York-based doctors filed a complaint against FDA in the U.S. District Court for the Southern District of New York seeking, among other things, a declaratory judgment that they can engage in truthful and non-misleading speech about an off-label use of Vascepa® (icosapent ethyl) without fear of criminal prosecution or civil liability.

While all of these developments are quite interesting, it’s unclear whether FDA intends to provide guidance anytime soon.  Last year FDA had signaled, through its responses to citizen petitions filed by the Medical Information Working Group, that some clarification would be forthcoming.  Now, with a public meeting to hear stakeholder views promised in the summer (but with no specific meeting details announced yet), it’s looking less likely that the agency is on the cusp of issuing new guidance on the increasingly fraught topic of off-label communication.

We’ll be tracking developments on this topic (and other advertising/promotion topics in FDA’s 2015 guidance agenda, such as health care economic information and use of links to third-party sites), so check back again.

CEO Media Statements Draw Additional Scrutiny

The Food and Drug Administration (FDA) has issued a second enforcement letter regarding a pharmaceutical company executive’s statements on television. On March 12, 2015, the Advertising and Promotional Labeling Branch (APLB) of the Center for Biologics Evaluation and Research (CBER) issued an Untitled Letter to Protein Sciences Corporation for a video interview posted to the company’s website. In an interview aired on a LifeTime morning show called “The Balancing Act”, the company’s Chief Executive Officer (CEO), Dr. Manon Cox, spoke about the company’s drug, Flublok (Influenza Vaccine).

Dr. Cox stated that Protein Sciences “is able to put three times more protein in there, so it is also a high dose vaccine. More protein means your body will form more antibodies that will help you fight the flu.” FDA found this claim misleading because it implied that the higher antigen content results in greater flu protection, and concluded it was unsubstantiated. According to the agency, it had previously advised the company that the claim was misleading. FDA also noted that the video presented multiple efficacy claims for the drug, such as “helps you fight the flu,” but omitted important safety information.

When FDA issued its first enforcement letter in November 2013 to a company for an executive’s statements to the media, we were cautiously optimistic that it would be a rare occurrence. Now, with a second letter, this seems more like a trend. As a result, we recommend that companies ensure that all media statements and talking points are reviewed by promotional review committees (PRCs) in advance.

Pursuant to the Untitled Letter, the Protein Sciences interview was removed from the company’s website, though it is still available on The Balancing Act’s website here.

The Protein Sciences Untitled Letter is available here.