Life Science Compliance Update

January 18, 2017

FDA Releases Draft Guidance for Medical Product Communications Consistent with FDA-Required Labeling

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The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product manufacturers, packers, and distributors, on how FDA evaluates firms’ medical product communications – including promotional materials – that present information not contained in the FDA-required labeling for the product, but that is consistent with such required labeling.

Various medical product firms have told the FDA that they would like to communicate data and information about the approved/cleared uses of their products, including information not contained in their products’ FDA-required labeling. As a result, the FDA issued this draft guidance for all drugs and devices, including those that are licensed as biological products, and animal drugs.

Because a communication that is consistent with a product’s FDA-required labeling could nonetheless misbrand the product and subject a firm to enforcement action if the representations or suggestions made in the communication are false or misleading, this guidance also provides general recommendations for conveying information that is consistent with the FDA-required labeling in a truthful and non-misleading way, as well as examples to illustrate these concepts. Interestingly, missing from the guidance document is any mention of off-label communications.

If a firm’s communication is consistent with the FDA-required labeling, that communication alone is not viewed by FDA as providing evidence of a new intended use. Further, FDA does not view a communication that is consistent with the FDA-required labeling as failing to comply with the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) requirement that a medical product’s labeling bear adequate directions for use, based solely on the fact that it presents data and information that are not reflected in the product’s FDA-required labeling.

Examples of Information that Could Be Consistent with FDA-Required Labeling

The following examples are listed as some of the examples the FDA provides of information that could be consistent with the FDA-required labeling.

  • Information based on a comparison of the safety or efficacy of a medical product for its approved/cleared indication to another medical product approved/cleared for the same indication (e.g., a firm’s communication provides information from a head-to-head study indicating that its drug that is approved to treat high blood pressure in adults has superior efficacy to another drug that is also approved to treat high blood pressure in adults);
  • Information that provides additional context about the adverse reactions associated with the approved/cleared uses of the product reflected in the product’s FDA-required labeling (e.g., the FDA-required labeling for a product identifies nausea as a potential adverse reaction and further indicates the product can be taken with or without food. A firm’s communication about the product provides information about how taking a product with food might reduce nausea);
  • Information about the long-term safety and/or efficacy of products that are approved/cleared for chronic use (e.g., a firm provides post-marketing information for its product, which was approved/cleared for chronic use based on 24-week study data, regarding persistent safety and/or efficacy over 18 months);
  • Information concerning the effects of a product that comes directly from the patient (i.e., patient-reported outcomes) when the product is used for its FDA-approved/cleared indication in its approved/cleared patient population (e.g., a firm’s communication provides information concerning patient compliance/adherence, or a firm’s communication provides information about patients’ perceptions of the product’s effect on their basic activities of daily living); and
  • Information that provides additional context about the mechanism of action described in the FDA-required labeling (e.g., the FDA-required labeling for a drug product indicates it exerts its effects by binding to a certain receptor, and a firm’s communication provides additional information about the product’s selectivity for that receptor).

Examples that Are Not Consistent with FDA-Required Labeling

The FDA also included some general types of information that they do not consider to be consistent with FDA-required labeling, some of which are below.

  • Information about the use of a product to treat or diagnose a different disease or condition than the product is approved/cleared to treat or diagnose (e.g., a product is approved/cleared to treat cardiovascular disease, and a firm’s communication provides information about using the product to treat diabetes);
  • Information about the use of a product to treat a different stage, severity, or manifestation of a disease than the product is approved/cleared to treat (e.g., a product is approved/cleared only to treat severe asthma, and a firm’s communication provides information about using the product to treat patients with mild asthma);
  • Information about using a product through a different route of administration or in a different tissue type than the product is approved/cleared for (e.g., a product is approved only for intramuscular injection, and a firm’s communication indicates the product can be injected intravenously); and
  • Information about the use of a product in a different dosage form than what is set forth in the FDA-required labeling (e.g., the product’s approved dosage form is a capsule, and a firm’s communication provides information about use of the product as an oral solution).

FDA Consideration Recommendations

The way a firm presents information that is consistent with the FDA-required labeling (including the express and implied claims made and the overall impression created by the communication as a whole) affects how the information is understood. The following are some high-level recommendations for firms to consider when developing their presentations of information that is consistent with the FDA-required labeling to help ensure the presentations do not mislead the applicable audience(s):

  • Any study results or other data and information that are relied upon to support a firm’s communication should be accurately represented in the communications. Moreover, material aspects of study design and methodology for any studies relied on should be clearly and prominently disclosed in firms’ communications to allow audiences to accurately interpret the information (e.g., type of study, study objectives, product dosage/use regimens, controls used, patient population studied), and material limitations related to the study design, methodology, and results should also be disclosed in a clear and prominent manner.
  • The communication should accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings. For example, if a firm presents efficacy results from a post-marketing study of its product that evaluated the effect of the product on two different endpoints, such as overall survival and progression-free survival, and the product failed to demonstrate an effect on one of these two endpoints, the firm should disclose this in the communication, rather than selectively presenting only the positive efficacy results.
  • For communications that present data or information that is not in the FDA-required labeling, but where the FDA-required labeling contains other data or information related to what is being represented/suggested in the communication, the communication should also include the data or information from the FDA-required labeling to provide the audience with appropriate context. For example, if a communication provides post-marketing information about the types and rates of occurrence of adverse events that have been observed in practice, the communication should also include information from the FDA-required labeling about the types and rates of occurrence of adverse reactions observed in clinical trials to provide context.

The guidance document also provides several examples for applicable audiences to review, and to determine if their situation is similar. The examples also provide a bit of extra insight into FDA’s thought process and goal with the guidance document. In general, guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on a topic and should be looked at only as recommendations, unless there are specific regulatory or statutory requirements cited.  

Planning for the Future - HHS OIG’s 2017 Work Plan

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Health and Human Services Office of Inspector General has released their 2017 Work Plan. The updated work plan includes some new and revised audits and evaluations, as well as some older audits and evaluations that OIG continues to focus on. This article goes through many of the items focused on the drug and device world and discusses what compliance officers should do with this Work Plan.

For the life science compliance professional, the issuance of the Office of Inspector General’s (“OIG”) Annual Work Plan is a highly anticipated event. It offers a window for manufacturers, providers, and payers into the primary areas of concern for the Department of Health and Human Services (“HHS”) on both a programmatic and enforcement level. As we have seen over the years, some of the areas of concern reflect persistent and concerning vulnerabilities that OIG has highlighted many times. However, the annual Work Plan also includes new and emerging issues that HHS will face in the upcoming year – and beyond.

Read the full article in the January 2017 issue of Life Science Compliance Update

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January 17, 2017

Democrat Senators Send Letter to Trump On Drug Pricing

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United States Senators Sherrod Brown (D-OH) and Al Franken (D-MN) led the charge to send a letter to President-Elect Donald Trump, outlining specific action items they would like to see his Administration taken to help Congress bring down the cost of prescription drugs. The letter was cosigned by eighteen other senators, including Patrick Leahy and Bernie Sanders (both of Vermont), Elizabeth Warren and Ed Markey (both of Massachusetts), Dianne Feinstein (D-CA), Dick Durbin (D-IL), and Kirsten Gillibrand (D-NY).

The letter expressed frustration shared by the senators over the cost of drugs and outlined several ways they believe Mr. Trump can make good on his promise to lower the rising cost of prescription drugs for consumers including: allowing the Secretary of Health and Human Services (HHS) to negotiate better prices for Medicare recipients; requiring drug companies to disclose costs associated with creating drugs so prices are more transparent; putting an end to abusive price gouging; and ensuring competition and innovation that will lead to greater competition and more affordable, effective drugs.

In the letter, the Senators wrote, “It is undeniable that more and more families are struggling to access medications, and in many cases, are forced to choose between paying for prescription drugs and other necessities, like food and shelter. The American public is fed up, with roughly 8-in-10 Americans reporting that drug prices are unreasonable, and that we must take action to lower costs. You now have the authority to push for a future that prioritizes patients. We are ready to advance measures to achieve this goal and we urge you to partner with Republicans and Democrats alike to take meaningful steps to address the high cost of prescription drugs through bold administrative and legislative actions.”

Candidate Donald Trump’s Positions

The letter referenced several promises made by President-Elect Donald Trump on the campaign trail. “During your campaign, you promised to implement bold reforms to bring down the cost of prescription drugs. In fact, you acknowledged that “Congress will need the courage to step away from the special interests and do what is right for America.” You also supported allowing consumers’ access to imported, safe, and dependable drugs from overseas and vowed to negotiate lower prescription drug prices for seniors. And earlier this month you again promised to “bring down drug prices.” While there are many different policy options to achieve lower drug prices, it’s clear that we all agree that all Americans deserve access to safe, effective, and affordable lifesaving medications. As Members of Congress, we are ready to advance bipartisan reforms that will help achieve the goal we all share: reducing the burden exorbitant drug prices are placing on hard-working Americans.”

In an interview with TIME ahead of Mr. Trump’s selection as TIME’s 2016 Person of the Year, he said he doesn’t “like what’s happened with drug prices” and that he will “bring down” the costs of prescription medication. On the campaign trail, Mr. Trump often called for allowing, or even going so far as requiring, Medicare to negotiate with drug companies to lower costs.

With his inauguration only days away, it will be very interesting to see how a President Donald Trump interacts with Congress – Democrats and Republicans alike. It will also be interesting to see how he governs, as there is not much (or, really any) prior experiences to look to for clues.

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