April 14, 2014

Zogenix Sues Massachusetts to Overturn Ban of Opioid Pain Drug

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for gavelgold.jpgZogenix, Inc., the San Diego-based manufacturer of the extended-release hydrocodone drug Zohydro ER, has sued the Governor of Massachusetts in U.S. District Court in Boston to overturn as unconstitutional the state's recent prohibition against prescribing and dispensing the medication.

Zohydro ER is the only FDA-approved hydrocodone drug indicated for daily, round-the-clock, long-term treatment of chronic pain for which other pain treatments are inadequate. The product, which was approved last year, is also the only available extended-release opioid drug containing hydrocodone alone, not combined with acetaminophen, which has been associated with liver damage.

The Governor of Massachusetts recently issued an "emergency declaration" establishing the ban, without consulting Zogenix, on the ground that a hydrocodone-only drug presents a greater risk of overdose and abuse than a hydrocodone combination drug. The ban would remain in place until "adequate measures are in place to safeguard against the potential for diversion, overdose and misuse."

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March 31, 2014

Foodborne Illness: How Do You Find Out If Your Food Might Cause Illness?

functional foods.jpgFoodborne illness affects approximately forty-eight million Americans per year, according to recent data from the CDC. Consumers have heard news stories warning of nationwide food recalls. What additional steps can be taken to ensure food safety? The FDA Food Safety Modernization Act was designed to address that question. Included in Section 211 of that Act are new provisions related to a Reportable Food Registry system (RFR) for increasing the speed of investigation and action to address foodborne illness (this is separate from FDA's recall program). Although FDA already had a public meeting in June 2011, the agency only received three comments, and believes it needs further input. So, on March 26, 2014, FDA published an advance notice of proposed rulemaking (ANPR) seeking public comment through June 9, 2014.

The proposal may require submission to FDA by a responsible party through the RFR of consumer-oriented information regarding a reportable food (information necessary to accurately identify whether a consumer possesses a reportable food) within twenty-four hours of discovery of an event. A "responsible party" is the person that submits a food facility registration related to the reportable food. A public health official may also submit a report, but not consumers. FDA would assess the information and publish a standardized one-page summary on its website for purposes of notifying consumers. FDA may require the responsible party to notify or provide contact information for upstream and downstream supply chain entities. Grocery stores that sold the reportable food would be required to prominently display that information within twenty-four hours of the FDA's website posting, and for a period of 14 days. FDA is required to develop a list of acceptable conspicuous locations and manners for grocery stores to post the information.

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Written by Laura Chubb

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"Consumer-oriented information" would include a description of the reportable food, production identification codes for the reportable food, contact information, and any other information for the consumer to identify the reportable food. "Reportable foods" are those "for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals." The new provisions will also not apply to fruits and vegetables.

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March 25, 2014

Bioavailability and Bioequivalence Draft Guidance for NDAs and INDs Issued by FDA

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for FDA.bmpFDA issued a draft guidance on March 18, 2014 titled, "Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations." This draft guidance seeks to revise and update FDA's March 2003 guidance titled, "Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -- General Considerations." This document provided guidance for NDAs, INDs, and ANDAs. In December 2013, FDA issued a draft guidance that deal with these issues solely for ANDAs. This week's draft guidance tackles the remaining portion of the subject matter in the 2003 guidance: NDAs and INDs. Like the draft guidance on ANDAs issued in last December, this March 2014 draft guidance should not surprise those familiar with FDA's bioequivalence ("BE") requirements; however, it helpfully clarifies and updates a number of long-standing Agency positions.

The instant draft guidance describes that BE documentation could be useful in the IND and NDA context to compare various formulations implicated at various stages of the application life-cycle. For example, BE studies may be useful in the pre-approval context to compare: (1) formulations used in various stages of clinical trials, (2) clinical trial formulations with formulations used in stability studies; (3) clinical trial formulations with proposed final formulations; and (4) product strength equivalence. In the post-approval context, BE studies are required by FDA under certain circumstances if the innovator makes changes to the formulation.

FDA's draft guidance issued this week also covers methods to document bioavailability and bioequivalence. It is not unexpected that the draft guidance devotes a significant portion to pharmacokinetic studies, laying out considerations relevant to study size, population, moieties to be measured, and pharmacokinetic measures of system exposure, to name a few. The usage of partial measures of exposure has been heavily debated in the past and this draft guidance confirms that they can be used in certain situations. The draft guidance also states, "[t]he time to truncate the partial area should be related to a clinically relevant PD measure." The draft guidance also covers in vitro tests with in vivo correlation, pharmacodynamic studies, comparative clinical studies, and in vitro studies. Further, the draft guidance provides considerations specific to dosage forms, such as solutions (and other solubilized dosage forms), immediate-release products, and modified-release products.

Continue reading "Bioavailability and Bioequivalence Draft Guidance for NDAs and INDs Issued by FDA" »

March 7, 2014

FDA proposes Changes to Nutrition Facts Label

foodlabel.JPGLast week, the Food and Drug Administration proposed an amendment to its labeling regulations for conventional foods and dietary supplements to update the nutrition information (e.g. the Nutrition Facts labels) on packaged foods/drinks. The updates would come from two proposed rules that are published in the Federal Register. The first--Food Labeling: Revision of the Nutrition and Supplement Facts Labels--addresses new scientific information and design changes; the second--Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments--addresses serving sizes, labeling requirements based on package size, and other issues.

FDA has grouped the proposed changes into three categories: (1) Greater Understanding of Nutrition Science; (2) Updated Serving Sizes and Labeling Requirements; and (3) Refreshed Design. Below is a summary of the significant proposals for each category.

1. Greater Understanding of Nutrition Science

  • New labels must include information about "Added Sugars"

  • Updated "Daily Values" for certain nutrients, including sodium, dietary fiber and Vitamin D

  • Require listing of potassium, Vitamin D, calcium, and iron amounts

  • Permit listing of Vitamins A and C amounts

  • Remove "Calories from Fat"

Continue reading "FDA proposes Changes to Nutrition Facts Label" »

February 27, 2014

FDA Adopts New Interpretation Awarding 5-Year NCE Exclusivity for Fixed Combination Drugs

multipills.jpgOn February 21, 2014, FDA issued a Draft Guidance that will now permit a fixed combination drug product containing a new active ingredient plus a previously approved active ingredient to qualify for New Chemical Entity (NCE) exclusivity, thereby preventing the filing of generic drug applications referencing the combination product for a period of 5 years. (A fixed combination drug is one containing more than one active ingredient, each in a fixed amount).

FDA's prior approach, in effect since 1994, had denied NCE exclusivity status to a fixed combination drug product that included an already-approved active ingredient. By virtue of the new Draft Guidance, the Agency is changing its interpretation of pertinent sections of the Federal Food, Drug, and Cosmetic Act and its own regulations. Going forward, FDA will determine NCE exclusivity by considering the newness of each drug substance (active ingredient) in a fixed combination drug product. If one active ingredient is new, NCE exclusivity can be awarded to the entire product.

As reasons for the change, FDA cites: (i) the emergence of combination drug treatment as a standard of care for serious diseases such as cancer, cardiovascular disease and infectious diseases (e.g., HIV), and (ii) the need to encourage the development of fixed combinations to treat these and other diseases, because particular combinations have been shown to improve treatment response, lower risk of resistance and lower rates of adverse events.

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February 21, 2014

Prescription Drug TV Advertisements--How Do You Know Which Are Actually the Serious Drug Risks?

TVad.pngYou can hardly watch television without seeing a prescription drug advertisement. Often the most memorable part of the advertisement is the required voiceover disclosing a long list of all the risks associated with taking the drug. The problem becomes deciphering which risks are actually the serious ones. FDA seeks to find out if that long disclosure of risks results in "reduced consumer comprehension, minimization of important risk information, and potentially, therapeutic noncompliance due to fear of side effects."

On February 18, 2014, FDA issued a notice seeking comments about its proposed collection of information - "Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads)." FDA proposes to investigate the impact of limiting the risk disclosure in prescription drug television advertisements to only those that are "serious and actionable" plus an alert that there are other risks associated with the drug but which are not disclosed in the advertisement.

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Written by Laura Chubb

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FDA would like to hear from you by April 21, 2014 about: whether you think its investigation is necessary "for the proper performance of FDA's functions;" whether the information will have practical utility; the validity of the methodology and assumptions its investigation will use; how the quality, utility and clarity of the information collected can be enhanced; and how the collection of information can be less burdensome on respondents.

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February 19, 2014

Leerink's Global Healthcare Conference 2014 Focuses on a Variety of Emerging Health Products

leerink.pngOn February 12 and 13, 2014, Leerink Partners LLC ("Leerink") held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference includes emerging themes in healthcare, where Leerink's equity analysts moderate discussions with MEDACorp specialists to provide unique and timely insights.

In addition to the company presentations, this year's line up featured the following panels or keynote speakers with some observed comments or trends:

• Panel: The Future of Medical Devices in an Evolving Landscape: A Shifting Emphasis to Patient Monitoring and Customizable Solutions

  • Patients view surgeons that incorporate robotics in their practice as the better doctors, driving more surgeons to utilize them in their practice. As surgeons become more familiar with these devices, patients may have more options for surgical procedures and implants.

  • Larger companies are looking at controlling infections caused by implanted medical devices with special coatings--either anti-infectives or antibiotics, particularly for use in higher-risk patients. There is an increasing need, however, for implants to have built-in tools for monitoring the devices. But as medical devices become more complex, such as hip, knee, or total joint replacements, these devices will require preapproval marketing applications ("PMAs") with clinical data rather than less costly and time-consuming 510(k)-type premarket clearance applications. Since PMAs cost companies more than 510(k) applications, these newer devices will cost third party payors and patients more.

  • Hospitals continue to be under a lot of pressure not to lose patients, so they may seek lower margins by having surgeons add anti-infective coatings or antibiotics rather than purchasing more costly versions with the coatings or by importing "generic" implants from other countries that may not be as rugged as the versions cleared for use in the U.S. FDA's new unique device identifiers and improved monitoring, however, may reduce use of such imported devices with unclear pedigrees.

Continue reading "Leerink's Global Healthcare Conference 2014 Focuses on a Variety of Emerging Health Products" »

February 18, 2014

FLH's Brian Malkin Featured in BioCentury TV This Week: The Battle Over Biosimilar Business Models

On Sunday, February 16, BioCentury This Week television examined the policies surrounding the expected competition of innovator biologic products with biosimilar versions. Featured in the program were interviews with:

  • Geoffrey Eich, Executive Director of R&D Policy at Amgen Inc.

  • Craig Wheeler, President & CEO of Momenta Pharmaceuticals Inc.

  • Brian Malkin Partner at Frommer Lawrence & Haug LLP and former Regulatory Counsel in the Office of the FDA Commissioner and the Center for Drug Evaluation and Research
.

Links to the interviews may be found below:

Brian Malkin

BioCentury 02.16.14 - [1] Safety v. Competition

Geoffrey Eich

BioCentury 02.16.14 - [2] Brand-Name Confidence

Craig Wheeler

BioCentury 02.16.14 - [3] Substitution Confusion

BioCentury 02.16.14 - [4] Competing Interests

February 14, 2014

BioCentury This Week: The Battle Over Biosimilar Business Models

BioCentury This Week.pngSunday, February 16: The Battle Over Biosimilar Business Models.

Biosimilars -- lower-cost versions of expensive biologics -- are coming to pharmacy shelves in the U.S. But biosimilars players disagree about how they should compete.

Should biosimilars be sold like inexpensive generic drugs? Or should they be sold at higher prices like branded drugs?

On Sunday, February 16, BioCentury This Week television examines the policies the two sides are fighting over with:

  • Geoffrey Eich, Executive Director of R&D Policy at Amgen Inc.

  • Craig Wheeler, President & CEO of Momenta Pharmaceuticals Inc.

  • Brian Malkin, Partner at Frommer Lawrence & Haug LLP and former Regulatory Counsel in the Office of the FDA Commissioner and the Center for Drug Evaluation and Research

Key opinion leaders; sophisticated questions
Always on BioCentury This Week television

Watch the Broadcast
8:30 - 9:00 a.m. EST
WUSA Channel 9
in Washington, D.C.

Watch on the Web
www.biocenturytv.com
Continuously available
starting at 9:00 a.m. EST

Get BioCentury This Week alerts on your mobile phone every week
text "BIO" to 25543 (standard text messaging rates apply).

February 7, 2014

FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition

DNApurple.jpgOn February 4, 2014, the U.S. Federal Trade Commission ("FTC") held a Workshop entitled: "Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition". The Workshop was well attended and sought to solicit a variety of views on the marketing of follow-on biologics, currently referred to as "biosimilars" under the Biologics Price Competition and Innovation Act ("BPCIA").

Briefly, the BPCIA defines "biosimilarity" as "[T]he biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product." A biosimilar is submitted as a 351(k) application, which must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and a clinical study or studies, unless FDA determines, in its discretion, that certain studies are unnecessary. To meet a higher standard of "interchangeability," an applicant must provide sufficient information to demonstrate biosimilarity, and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. According to the BPCIA, interchangeable biosimilar products may be substituted for the reference product without the intervention of the prescribing healthcare provider.

As explained by Edith Ramirez, FTC Commissioner, many state legislatures have either passed or are considering legislation to explain how to handle biosimilars that are not interchangeable (and sometimes including interchangeable biosimilars), which may affect competition for the market at this juncture before even one biosimilar has been approved. In particular, many of the state laws or bills include provisions for prescriber notification of possible biosimilar substitution for the referenced innovator biologic product. FDA and other regulatory bodies are still considering universal nomenclature for biosimilars, which may either create the same or similar names for biosimilars and their referenced innovator biologic products. The FTC sees similarities between biosimilars and how generics were first perceived and opportunities to either facilitate or hinder acceptance of biosimilars in the market that they wanted to explore in this Workshop.

Continue reading "FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition" »

February 3, 2014

REMS Summit Hosted by ExL Pharma Delivers Thought-Provoking Stakeholder Discussion

Banner REMS.pngOn January 28-29, 2014, ExL Pharma hosted its 6th Annual Risk Evaluation and Mitigation Strategies ("REMS") Summit in Alexandria, Virginia. For the first time since the Summit has been held, key members from the FDA's Division of Risk Management attended. In particular, Claudia Manzo, Director, FDA Division of Risk Management, spoke in the main opening panel along with FLH Partner Brian J. Malkin and Yola Moride, Ph.D., FISP, Professor, Université de Montréal. The opening panel featured a discussion of some key take aways from FDA's Public Meeting on Standardizing and Evaluating REMS in July 2013 and follow-up meeting in December 2013 to identify and discuss new methods for communicating risk information as part of REMS to health care providers and its target populations. The Summit also featured a pre-conference workshop on regulatory negotiation and internal and external audits for REMS, as well as a concluding roundtable session, which focused on some of the key topics raised. The Summit was closed to the media to help encourage a free exchange of ideas.

As promised, the Summit built upon recent REMS events and discussions featuring the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies to share their perspectives, experiences, and leverage the discussions in a well-rounded and interactive platform to take a proactive approach covering:

  • Recent developments and initiatives

  • Possible frameworks for standardization

  • Tools for evaluation

  • Best practices for modification

  • Methods to measure the burden

  • Lessons learned from various REMS programs

  • Innovative approaches to improve REMS effectiveness

  • What can be learned from other industries

  • Challenges working in single shared REMS.

Tempered by thoughtful observational comments provided by the Summit's Chairperson, Mibhor D'Silva, Vice President Safety and Pharmacovigilance, Astellas, and insight from the various keyholders, Summit participants were not only challenged to provide their opinions but also their insight for improving REMS going forward. While many of the discussions focused on the impact of REMS on healthcare settings or health care providers, the goal of REMS to provide better patient risk information and treatment outcomes was also emphasized. Many of the participants commented that they learned much from each other, in particular the logistics of REMS implementation in health care settings, where updates are a constant challenge.

If you have any comments or ideas to share or are interested in speaking at the 7th REMS Summit in 2015 please contact Kai Hahn, Senior Conference Director, khahn@exlpharma.com.

January 31, 2014

Liquid Dietary Supplements and Beverages: How Do You Distinguish?

liquids.jpgWhether a beverage or a dietary supplement, liquid products are marketed more than ever before--now containing a wider array of ingredients, for many more intended uses and including traditional food substances, but at levels far exceeding previously used amounts. So how does one know if a liquid product is a beverage or a dietary supplement? And what regulations must be followed? To answer those questions, FDA has issued nonbinding recommendations in two new guidances this month: Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. FDA hopes that these guidances will help the industry avoid misbranding with inconsistent product category labeling and adulteration for failure to meet the proper regulations.

When distinguishing between beverages and dietary supplements, as a general rule, dietary supplements are meant to supplement the diet, and beverages are for quenching thirst and providing fluid, nutritive value, taste or aroma. FDA's Guidance sets out the following factors to consider in distinguishing between the two types of liquid products: labeling and advertising, product name, product packaging, serving size and recommended daily intake, recommendations and directions for use, marketing practices, and composition of the liquid product. The Guidance provides examples of how the factors can come into play in a determination. It is likely that a combination of factors, not one, will be determinative of a product's category. For example, even if the label of a liquid product contains a Supplement Facts Panel, it could still be considered a "beverage" if it also contains a statement that the product "refreshes," or the product could be a "food" if the label contains a picture of the liquid being poured onto a salad. The product name could also be determinative that a product is likely a "beverage", if the product name contains conventional terms for beverages, like "drink", "soda", "orange juice", "iced tea", "bottled water", or "coffee". The product packaging is another determinant and, if the packaging is reclosable, is shaped similar to a common beverage package, or contains a single serving, then it is likely a "beverage". The serving size or recommended daily intake may also indicate which category a liquid product falls under. For example, if the product is intended to be consumed all at once or contains a significant part of the entire daily drinking fluid intake for the average person then it is likely a "beverage". Interestingly, marketing practices, another factor, such as metatags for "sodas," "juices" or "beverages," or paying for store shelf placement with other beverages could be determinative of a "beverage". But the product is not necessarily a "beverage" if the marketing says the product should be taken with a meal, since dietary supplements are often recommended for use along with a meal. Finally, the composition of a liquid product may be determinative, although there is a lot of overlap now with both categories containing amino acids, proteins, and vitamins. Similarly, merely adding a dietary ingredient does not make a product a "dietary supplement".

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Written by Laura Chubb

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Once the factors are considered to determine whether a liquid product is a "beverage" or a "dietary supplement", the type of product controls which regulations must be met. For beverages, a substance can be generally recognized as safe ("GRAS") for its intended use based upon generally-available evidence of safety recognized by experts. But unless GRAS for its intended use or exempt, substances intentionally added to "beverages" are "food additives", which require premarket approval based upon safety data. FDA issues regulations for approved food additives that specify the conditions for which the substance is safe and can be used. Accordingly, non-dietary ingredients added to supplements, such as binders, excipients and fillers, however, must meet food additive requirements or be GRAS. On the other hand, dietary ingredients included in dietary supplements are not required to be GRAS and are exempt from food additive regulations but still must not be adulterated, and, if new, must meet new dietary ingredient requirements. No matter a "beverage" or "dietary supplement", the guidances remind the industry to make sure the labeling is not false or misleading, and if included, to make sure health claims, nutrient content claims, and structure function claims are proper.

January 28, 2014

Pay For Delay -- Supreme Court's Actavis Decision Is Limited to Monetary Payments

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn January 24, 2014, Judge Walls of the U.S. District Court for the District of New Jersey dismissed the In re Lamictal Direct Purchaser Antitrust Litigation after concluding that the U.S. Supreme Court's FTC v. Actavis ruling concerning the antitrust implications of so-called "pay-for-delay" settlements of Hatch-Waxman patent infringement cases only "applies to patent settlements that contain an unjustified reverse payment of money."

The settlement in this case ended a patent infringement action between branded pharmaceutical manufacturer GlaxoSmithKline ("GSK") and generic manufacturer Teva Pharmaceuticals ("Teva"). The settlement "allowed Teva to market generic lamotrigine [Lamictal®] before the relevant patent expired and ensured that once it did so, its generic tablets and chewables would not face competition from GSK's own 'authorized generic' for a certain period of time."

Direct Purchaser plaintiffs Louisiana Wholesale Drug Company and King Drug Company of Florence brought the present antitrust action against GSK and Teva, "alleg[ing] that the settlement violates federal antitrust laws." The district court dismissed the case a first time in December 2012 for failure to state a claim under the then-existing antitrust laws. The Direct Purchasers appealed. While the appeal was pending, the Supreme Court issued its Actavis decision. As a result, the Third Circuit Court of Appeals remanded the case back to the district court for reconsideration of its earlier dismissal based on Actavis.

Continue reading "Pay For Delay -- Supreme Court's Actavis Decision Is Limited to Monetary Payments" »

January 22, 2014

FDA Approval: JAMA Takes a Closer Look to Help Evaluate the Strength of Evidence for Physicians and Patients

AMAHQChicago.pngOn January 22, 2014, the Journal of the American Medical Association ("JAMA") took a closer look at the FDA approval process for drugs and medical devices. On the surface these studies were designed to characterize the type of pivotal data relied on by FDA for approval (or denial) of new drugs and devices. The conclusions from these studies and some of the associated "Opinion" articles suggest, however, that the editors of JAMA, and perhaps its members, believe that FDA should make physicians and patients more acutely aware of the information relied on for new approvals, as well as side effects observed following approval.

The main article, entitled "Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012", took as a starting point that physicians and patients do not understand or have the tools to evaluate the different strengths of clinical evidence used by FDA to approve new drug and device therapies. Based on an Internet-based study, for example, the study reported that a national sample of 4316 adults (68% response rate) found that 39% believe FDA approves only "extremely effective" drugs and 25% only drugs without adverse events, which the authors said may reflect the opinions of some physicians.

Taking a closer look at these approvals, the authors concluded:

Our characterization of pivotal efficacy trials . . . demonstrates that the quality of clinical data evidence used by FDA to make approval decisions varied widely across indications. Although the vast majority of indications were supported by at least 1 randomized, double-blinded trial, there was wide variation in trials' choice of comparators and end points, duration, size, and completion rate. In addition just more than one-third of indications were approved on the basis of a single pivotal efficacy trial.

Continue reading "FDA Approval: JAMA Takes a Closer Look to Help Evaluate the Strength of Evidence for Physicians and Patients" »

January 17, 2014

Interactive Promotional Media Guidance (Social Media Plus) Issued in Draft by FDA

socialmedia.jpgEarlier this week, FDA released a new draft guidance, "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics". This Guidance is a long-anticipated guidance regarding how FDA views what it calls "interactive promotional media" including what is commonly referred to as "social media", e.g., Facebook, Twitter, blogs, as well as networking sites, live podcasts, and online communities. In particular, FDA describes how applicants/sponsors ("firm") are expected to comply with providing the firm's promotional activities in this arena.

First, FDA explained that a firm is accountable for all promotional activities that are carried out by the firm or on the firm's behalf, including communications about the firm's product(s) that may be influenced or controlled in whole or in part by the firm. In this regard, FDA provided specific examples to illustrate the following principles:

  1. A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.

  2. Under certain circumstances, a firm is responsible for promotion on third-party sites.

  3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm's product.

Some of the nuances described in the examples clarify that a firm's mere financial promotion of a site is not sufficient to trigger inclusion of the site as part of the firm's promotional activities. If a firm merely provides information to be included in the site, then the firm is responsible to provide that content to FDA as promotional activities. Whenever the firm has some influence or control over the content or placement of content, then the firm needs to provide the full site or partial site. If only influencing placement, the actual information and surrounding pages may be provided to put the placement in context. FDA, however, will not review user-generated content ("UGC"), e.g., message boards and chat rooms, that is "truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular)."

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