Draft guidance seeks to make drug labels clear, concise, more consistent

In an effort to assist applicants in writing the Indications and Usage section of labeling for human prescription drug and biological products, the FDA issued a new draft guidance. The FDA’s intent is to make information in prescription drug labeling easier for health care practitioners to access, read, and use. The goal of the guidance is to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes (Notice, 83 FR 31759, July 9, 2018).

Indications

The Indications and Usage section should clearly communicate the scope of the approved indication, including the population to which the determination of safety and effectiveness is applicable. The guidance includes information on how and when evidence may support approval of an indication that is broader or narrower in scope than the precise population studied.

The indication should begin “Drug X is indicated” and be followed by the disease, condition, or manifestation of the cease or condition being treated, prevented, mitigated, cured, or diagnosed, and when applicable other information necessary to describe the approved indication. The other information may include selected patient subgroups or disease sub populations for whom the drug is approved, adjunctive or concomitant therapy or therapeutic modalities to use before initiation drug therapy, or specific tests needed to select patients in whom to use the drug.

Limitations of use

Limitations of use should be presented separately from the indication and should only be included when the awareness of such information is important for practitioners to ensure the safe and effective use of the drug. Limitations of Use are appropriate for drugs for which there is reasonable concern or uncertainty about effectiveness or safety in a certain clinical situation, drugs approved without evidence of benefits known to occur with other drugs in the same class, or drugs with dose, duration, or long-term use considerations.

Language

Certain products have statutory or regulatory required or recommended language for the Indications and Usage section. The guidance includes preferred wording and wording to generally avoid. For example, the guidance explains why it is better to use the phrase “reduce the risk” or “reduce incidence of” rather than using “prevent” in the indication. It also discusses when the terms “only” and “also indicated” should be avoided. Finally, product should be identified by the proprietary name or trade name if it has one, and other information such as the dosage form, and route of administration should not be included in the indication.

 

FTC nails opiate withdrawal supplement company for misleading statements

Catlin Enterprises, Inc. (Catlin) is now barred from making scientifically unsubstantiated claims that their opiate withdrawal treatment alleviates withdrawal symptoms and increases the chances of overcoming opiate dependency. A Texas district court ordered the permanent injunction following the Federal Trade Commission’s (FTC) complaint against Catlin.

Complaint and order

The FTC alleged that Catlin falsely advertised its products Withdrawal Ease and Recovery Ease and participated in deceptive acts throughout the process of labeling, advertising, distribution, and sale of the products. According to Catlin’s statements, Withdrawal Ease significantly alleviates opiate withdrawal symptoms and significantly increases the likelihood of overcoming dependency, while Recovery Ease significantly alleviates post-acute withdrawal symptoms.

The injunction prevent Catalin and its officers, agents, employees, and other people actively participating in the company from engaging in any steps of the process of making and selling any dietary product intended to provide withdrawal assistance or other health benefits and represented as having such benefits unless such statements are not misleading. Any representation of benefits much be based on reliable scientific evidence, obtained from human clinical testing of the product or an equivalent product. The testing must be conducted by qualified researchers and be randomized, double-blind, and placebo controlled.

A $6.6 million judgment was entered and suspended premised upon the accuracy of sworn financial statements. Catalin must provide the FTC with customer information to allow the FTC to “administer consumer redress,” when requested, then destroy this information when instructed to do so by the FTC.

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.