Life Science Compliance Update

January 18, 2017

FDA Releases Draft Guidance for Medical Product Communications Consistent with FDA-Required Labeling


The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product manufacturers, packers, and distributors, on how FDA evaluates firms’ medical product communications – including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 As a result, the FDA issued this draft guidance for all drugs and devices, including those that are licensed as biological products, and animal drugs.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.  

January 12, 2017

President-Elect Donald Trump Lambasts Pharmaceutical Industry

On Wednesday, January 11, 2017, President-Elect Donald Trump held a news conference in New York; a conference that was held out for weeks to be the time when the country could expect learn what he would be doing with his vast real estate and other investment holdings.

Vice President-Elect Mike Pence

Vice President-Elect Mike Pence spoke first, noting that Mr. Trump has “brought together men and women of extraordinary capability at a historic pace in this cabinet.” He continued, noting that “nineteen of the twenty-one cabinet officials have been announced, nine committee hearings already scheduled, seven more soon to go on the books in the next several days…”. He then touched upon the “fake news” versus “real news” controversy the country has been mired in for the past couple weeks, segueing into his introduction of Mr. Trump by saying, “we’ll hear from the president-elect about issues that are of paramount importance to the American people today.”

President Elect Donald Trump

Mr. Trump first touched on the fact that this was his first news conference in awhile, starting what has become his typical modus operandi – complimenting those who help him and make him look good, and slighting those who have perhaps run less-than-positive stories on him.

He then started discussing what he has already accomplished, especially with respect to keeping jobs in America in the automobile industry, mentioning Ford, Fiat Chrysler, and possibly General Motors as companies who have announced keeping jobs in America. After that is where our interest was really piqued: Trump went in on the pharmaceutical industry.  

Pharmaceutical Industry Comments

Quoting Mr. Trump,

We’ve got to get our drug industry back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don’t make them here, to a large extent. And the other thing we have to do is create new bidding procedures for the drug industry because they’re getting away with murder.

Pharma, pharma has a lot of lobbies and a lot of lobbyists and a lot of power and there’s very little bidding on drugs. We’re the largest buyer of drugs in the world and yet we don’t bid properly and we’re going to start bidding and we’re going to save billions of dollars over a period of time.

These comments by Mr. Trump are not exactly new news, as he pledged to overhaul the pharmaceutical industry during his campaign. During the campaign, he expressed his desire to crack down on high drug prices and even endorsed the concept of Medicare negotiating drug prices.  

Reaction to Comments

His remarks today won him an unlikely ally, Bernie Sanders, who said during a Senate floor speech that Trump was “exactly right.” His comments also sounded similar to those made by Hillary Clinton on price gouging during the presidential campaign.

Pharmaceutical Research and Manufacturers of America (PhRMA) President Stephen Ubl said, "Medicines are purchased in a competitive marketplace where large, sophisticated purchasers aggressively negotiate lower prices." He said the industry is "committed to working with President-elect Trump and Congress to improve American competitiveness and protect American jobs."

News Conference, Continued…

Mr. Trump did continue, speaking about several other hot-button topics, and then took questions, most of which focused on Russia and the possible hacking that occurred. After a brief question and answer session, Mr. Trump turned control of the conference over to Sheri Dillon, who discussed how Mr. Trump plans to handle conflicts of interest. After a brief explanation, Mr. Trump again started taking questions – these more focused on potential conflicts of interest in his cabinet, Obamacare (repeal and replace), the Supreme Court, the wall along the Southern border of the U.S., and even more on Russia.

December 21, 2016

Why Do People Believe Drugs Are Too Expensive?


We have long heard from the media that the pharmaceutical industry “over charges” for prescription drugs and “makes money at the sake of those who can least afford it.” Public examples such as Turing, Mylan, and Valeant helped drive those narratives home. However, a poll done by the Kaiser Family Foundation (KFF) found that may not be the case. The polls were done throughout 2015 and 2016 and were related to public opinion on prescription drugs and their prices. 

Perhaps one of the most interesting findings in the entire report was that seventy-seven percent of the public says the cost of prescription drugs is unreasonable, but among those taking prescription drugs, seventy-three percent say affording them is easy. Only one in four prescription drug users (roughly fourteen percent of the overall population) say it is difficult to pay for their drugs.

Other Key Findings of the Report

The report included other key findings on public opinion of industry, including:

  • While fifty-six percent of the public says that prescription drugs developed over the past twenty years have made the lives of people in the U.S. better, fifty-three percent have an unfavorable opinion of pharmaceutical companies.
  • Seventy-three percent say they think drug companies make too much profit, compared to twenty-one percent who say drug companies make about the right amount of profit and just one percent who believes they don’t make enough profit.
  • Seventy-four percent of the public thinks people in American pay higher prices for the same prescription drug than patients in Canada, Mexico, and Western Europe.
  • Large percentages favor actions to lower drug costs, such as requiring drug companies to publicly release information on how prices are set, allowing the government to negotiate prices in Medicare Part D and limiting the amount drug companies can charge for high-cost drugs for illnesses like cancer.
  • Sixty-two percent of the public, including fifty-four percent of Republicans, think there is not as much regulation as there should be when it comes to limiting the price of prescription drugs. However, a majority of those polled believe market competition does a better job at keeping prescription drug prices down than government regulation does.
  • Seventy-seven of those polled believe pharmaceutical profits are a major factor contributing to prices, but also acknowledge that there are other factors contributing to prices, such as medical research (sixty-four percent), marketing and advertising (fifty-four percent), and lawsuits against drug companies (forty-nine percent).

Potential Solutions

While many have pointed to Congress as having the answer and solution to resolve the issue of presumed high drug prices, “prospects for legislative change are not high and are probably a little ways off,” according to Dr. Aaron Kesselheim of Harvard Medical School. He continued, noting, “But maybe things are starting to change in a way that might provide an opening for some reform.”

According to Chip Kahn, CEO of the Federation of American Hospitals, “It’s hitting the point where the drug cost issue has got everyone’s attention, but I’m not sure what the coalition would be that would support heavy-handed government intervention.”

However, as noted previously, the vast majority of patients who rely on medications do not have a problem affording their medication. While that does not necessarily mean there is no room for improvement on prescription prices, it does mean that there is a bit of a perception gap. Pharmaceutical manufacturers should continue to espouse all of the beneficial things they do to help patients, including patient assistance programs, focusing on the research and development of new and improved courses of treatment, and highlighting the value prescriptions provide for patients.


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