Court imposes 10-month deadline for pre-market tobacco applications

A federal district court in Maryland has set a deadline of 10 months for tobacco product manufacturers to submit pre-market applications and a one year deadline for FDA approval. The court previously concluded that the FDA violated the Administrative Procedure Act (APA) when it released guidance in 2017 extending the compliance deadline for the “Deeming Rule” which brought new tobacco products under the purview of the Family Smoking Prevention and Tobacco Control Act. Rather than remanding the issue to the FDA to determine a timeline for compliance or accepting the plaintiffs’ request of a four-month deadline for applications, the court accepted the FDA’s recommendation of a 10-month deadline. The court found that it has the authority to impose such a deadline under the extraordinary circumstances of the case, in which prompt action is necessary to combat the public health crisis caused by the rise in youth e-cigarette use (American Academy of Pediatrics v. FDA, July 12, 2019, Grimm, P.).

FDA tobacco rule compliance extensions

On May 10, 2016, the FDA issued the “Deeming Rule,” bringing approximately 25,000 new tobacco products, including various cigars, e-cigarettes, pipe tobacco products, and hookah within the purview of the Family Smoking Prevention and Tobacco Control Act. The Deeming Rule went into effect 90 days after its publication (see FDA clears the air, ‘deems’ e-cigarettes, hookah tobacco, cigars worthy of regulation, Health Law Daily, May 10, 2016). In May 2017, the FDA extended the compliance deadline by three months. In August 2017, the FDA extended the timelines to submit tobacco product review applications for deemed tobacco products that were on the market as of August 2016. In May 2019, the district court ruled that the FDA’s August 2017 compliance deadline extension violated the Administrative Procedure Act, as it was done without following notice and comment requirements. The court vacated the August 2017 Guidance and asked the parties to brief the court on potential remedies, given that the application deadlines in the Deeming Rule and May 2017 Guidance had passed.

Remedy

The court concluded that the case presented “extraordinary circumstances” that called for more than simply vacating the guidance and remanding the issue to the FDA (as was requested by manufacturers). It imposed a 10-month deadline for submissions and a one-year deadline for approvals, as suggested by the FDA. The plaintiffs had requested a four-month deadline for submissions, but the court rejected that solution because of the record from the FDA demonstrating that a four-month deadline would prevent them from timely approving or denying applications and could clear the market of e-cigarette products, thus creating a risk that adult smokers would switch from e-cigarettes to combustible tobacco products. The FDA also presented evidence that it plans to accelerate the premarket review requirements for the products that are most attractive to youth, such as flavored products.

The court concluded that without a deadline for filing, manufacturers would be unlikely to move forward with applications, because the record showed a purposeful avoidance by the industry of complying with the premarket requirements despite entreaties from the FDA that it can do so, and it establishes a shockingly low rate of filings.

FDA considers establishing a new ‘Office of Patient Affairs’

The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more transparent, accessible, and robust experience for patient communities, the FDA is considering establishing a new Office of Patient Affairs.

On November 4, 2014, the FDA established a docket (FDA-2014-N-1698) for the public to submit information related to the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), Patient Participation in Medical Product Discussions under FDASIA section 1137.

Based on the comments received, the FDA identified objectives for its patient engagement activities. First, to develop a nuanced understanding of the patient experience of disease by: (1) gathering patient perspective on what is clinically meaningful; (2) assessing attitudes towards benefit-risk and tolerance of uncertainty; and (3) enhancing the science of eliciting and integrating patient input.

Second, to support patients and their advocates in understanding regulatory processes and navigating the FDA by: (1) communicating relevant FDA positions, procedures, and activities; (2) connecting patients and their advocates with the appropriate resources; and (3) resolving discrete challenges and needs.

To achieve these objectives, the FDA is considering establishing a central “Office of Patient Affairs.” The responsibilities of this central office would include:

  • offering a single, central entry point to the FDA for the patient community;
  • providing triage and navigation services for inbound inquiries from patient stakeholders;
  • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and the FDA’s relationships with patient communities; and
  • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The Office of Patient Affairs would be directly accountable to the medical product Centers. A regular evaluation of this central office and of FDA’s overall patient engagement efforts are also proposed.

 

 

Life sciences industry groups ask for indefinite stay, say FDA strayed

The Final rule titled Clarification of When Products Made or Derived From Tobacco Are Regulated As Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (82 FR 2193, January 9, 2017) violates the Administrative Procedures Act (APA) (P.L. 79-404) and constitutes an overstep of the FDA’s authority, according to a petition for an indefinite stay of the rule’s implementation, filed by the industry groups, Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The petition focuses primarily on the second part of the Final rule, asking the FDA to indefinitely halt implementation of the Final rule’s new “intended use” policy.

Petition

The petition asserts, by not adequately informing the public of changes to the “intended use” doctrine, the FDA’s final rule violates the APA.  The substance of the petition argues by not including the “intended use” changes prior to the publication of the Final rule, on January 9, 2017, the industry groups were deprived of the fair notice and hearing required by the APA. Instead of being a permissible “logical outgrowth” of the proposed rule, the industry groups assert that the FDA strayed too far beyond the Proposed rule (80 FR 57756) and engaged in “a fundamental change to the regulatory scheme for drugs and devices.”

Intended use

Section 502(f)(1) of the Food, Drug, and Cosmetics Act (FDC Act) requires that drug and device labeling contains “adequate information” regarding any “use for which [the drug or device] is intended.” The doctrine was codified at 21 C.F.R. Sec. 201.128 (for drugs) and at 21 C.F.R. Sec. 801.4 (for medical devices). The FDA doctrine includes the following provision: “if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug or device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.”

The petitioners object to the above, the FDA’s pre-rule regulatory position, and were, instead, supportive of the position set out in the Proposed rule, which would have established a position where the FDA would no longer “regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”

Totality of the evidence

The industry groups challenge what they call the totality of the evidence standard, which, they say, the FDA presented for the first time in the Final rule, a doctrine under which a manufacturer would be required to provide adequate labeling for all intended uses, if the “totality of the evidence” indicates the manufacturer intends for a drug to have off-label uses. The petition asserts that by establishing such a requirement, the Final rule will violate the First Amendment to the U.S. Constitution, chilling truthful and non-misleading promotional speech.

Review

The petition is currently under FDA review. There are currently no pending resolutions to disapprove the rule in Congress.

 

FDA issues warning statements for cigars, guidance on warning plans

Although the FDA took five years from the passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Act) (P.L. 111-31) to extend its regulatory authority to cover cigars, it has now issued guidance on required warning statements for cigar products. By May 10, 2018, cigars may not be manufactured, packaged, sold, offered for sale, or imported for sale or distribution without one of several warning statements appearing on product packaging. Manufacturers may not distribute products in non-compliant packaging beginning June 11, 2018.

Final rule and new regulations

The Tobacco Act, enacted June 22, 2009, granted the FDA the authority to deem statutorily defined tobacco products as subject to the agency’s regulation. The FDA did so through a Final rule (81 FR 28974), which established the FDA’s authority over any product made or derived from tobacco and intended for human consumption. These regulations establish responsibilities of manufacturers, distributors, and retailers, which include proper presentation of warning statements and the submission of warning plans (21 C.F.R. parts 1100-1143).

Required statements

As of the effective date, all cigar packages and advertisements must contain one of the following statements:

  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  • WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  • WARNING: Cigar smoking can cause lung cancer and heart disease.
  • WARNING: Cigars are not a safe alternative to cigarettes.
  • WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  • WARNING: Cigar use while pregnant can harm you and your baby.
    or
  • SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

Although retailers are subject to the regulations, they will not be considered in violation of these requirements if the cigars offered for sale contain a health warning, are supplied from a source that has the required licenses or permits, and are not altered by the retailer in a meaningful way. Individually sold cigars without packaging are exempt from packaging requirements, but retailers must post a warning sign with all six warning statements at the point of sale.

Warning plans

The requirement to submit warning plans to the FDA for cigars will take effect May 10, 2017. These plans must provide that all warning statements are displayed in each 12-month period, on each product brand, and are randomly displayed as equally as possible and randomly distributed in all areas of the US.

Generally, for packaged cigars, the FDA believes that the brand manufacturer is best able to ensure that the warning plan contains sufficient information for approval and that the packaging complies with the requirements. If a product is manufactured under contract, the contracting entity is best suited to submit the plan. Importers of finished cigars usually control packaging and distribution, and should submit the plan. Usually, retailers should not submit warning plans, unless they are responsible for the placement of warning statements.