Weekly Roundup 2.27.15

Another round of snow this week, perhaps the last gasp of winter? I can’t say there is any hint of Spring in the air in these parts, but sure hope there is where you are. In any event, I am happy to say goodbye to February and here is a bit of what happened this week:

  • Approval of Multiple Myeloma Treatment - In one of the rather rare examples of FDA not following a recommendation of one of its advisory panels, FDA this week announced approval of the first histone deacetylases (HDACs) inhibitor, Farydak, for the treatment of multiple myeloma. The treatment is being indicated for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulator agent. It is to be used in combination with bortezomib and dexamethasone. FDA notes in its press release that while the advisory committee did not offer a recommendation for approval that the company submitted post-meeting information for a different indication. Clinical studies showed that study subjects receiving the treatment experienced a delay in disease progression. There will be a boxed warning for the label. This was another priority review by FDA with orphan designation and was considered under the accelerated approval program allowing for access during confirmatory clinical trials. The company’s multimedia news release can be found here.
  • FDA Approves Antibacterial – The agency announced approval of antibacterial Avycaz (ceftazidime-avibactam) to treat adults with complicated intra-abdominal infections in combination with metronidazole.  Also approved for complicated urinary tract infections, including kidney infections where there is limited or no alternative treatment opions. The product is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor. This was a priority review for FDA and had Qaulified Infections Disease Product (QDIP) designation which confers an added 5-year exclusivity period. The company release can be found here.
  • AdComm for Second Biosimilar Postponed – Two weeks ago the Weekly Roundup reported that an Arthritis Drugs Advisory Committee meeting had been scheduled – the second to consider a biosimilar. The product is a biosimilar for the reference product Remicade® (infliximab). However, the date which was set for March 17 was changed to date to be specified at another time. The agency said that the delay was due to pending information requests with the sponsor of the application.

That’s it for me this week folks.  Have a good weekend!

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Legislative Proposals in the 114th Congress

Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed.  The new Congress has just two months old and while the last Congress was not among the most productive, there has been some legislation that was proposed in the 113th that has resurfaced in the 114th.

Some of the more notable highlights include proposals to expand assets – to allow for the importation of drugs from Canada and one to open up pathways to investigational drugs.


  • H.R.244 - Pharmacy Benefits Manager Standards - A bill to set standards for pharmacy benefit managers to further transparency of payment methodologies. Introduced by Rep. Doug Collins. a/k/a The MAC Transparency Act.
  • H.R.271 – Creating Options for Veterans Expedited Recovery Act -would establish a commission to examine the evidence-based therapy treatment model used by the Secretary of Veterans Affairs for treating mental illnesses of veterans the potential benefits of incorporating complementary alternative treatments in non-DOVA medical facilities.
  • H.R.406 - Combination Drug Development Incentive Act – Introduced by Congressman Jason Chaffetz with no co-sponsors as of 2/11/15 – would provide incentives for the development of combination drugs. No companion bill as of 2/11/15.
  • H.R.471 - Prescription Drug Diversion - to improve enforcement efforts related to diversion and abuse. As of 1/28/15, no title, no summary available.
  • H.R.790 - Compassionate Freedom of Choice Act of 2015 - would allow the manufacture, importation, distribution and sale of investigational drugs and devices intended for use by the terminally ill who execute informed consent introduced by Congressman H. Morgan Griffith with one co-sponsor as of 2/25/15 and no companion bill in the Senate.


  • S 31 – Medicare Prescription Drug Price Negotiation Act - Introduced by Senator Amy Klobuchar would allow HHS to negotiate prices for drugs under Medicare Part D.
  • S.122 - Safe and Affordable Drugs From Canada Act - Introduced by Senators McCain and Klobuchar would allow Americans to order prescription drugs from approved pharmacies in Canada.
  • S.131 - Fair Generics Act - Introduced by Senator Vitter and co-sponsored by Senator Franken, a retread from the last Congress, the bill would amend Hatch-Waxman to address practices whereby it is perceived that manufacturers seek to delay the entry of generics to the market.
  • S.185 - PATH Act - Introduced by Senator Orrin Hatch would create a limited population pathway for the approval of certain antibacterial drugs meaning that approval of the drug could be made for a select population where there is an unmet need or life-threatening condition.  Also known as the “Promise for Antibiotics and Therapeutics Act”.
  • S.481 - No TitleWould change the way drug scheduling is recommended by HHS. The bill has one co-sponsor, no companion bill as of 2/25/15.
  • S.483 - Bill to Improve Enforcement Efforts Related to Prescription Drug Abuse and Related Purposes - Introduced by Senator Orrin Hatch, 1 co-sponsor, no companion bill as of 2/25/15.

The legislative overview will be periodically updated on the “Proposed Legislation – 114th Congress” tab on the EyeonFDA blog site.

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Weekly Roundup 2.20.15

Friiiiiiggggggiiiiiiiddddd.  I realize anyone who doesn’t live in the Northeast can’t really complain, but winter finally woke up in the capital of our nation. Last week I took a picture of green daffodil sprouts coming up from the grounds of the library in my neighborhood and remarked on Facebook that it was a harbinger of Spring. This week, after snow that came horizontally instead of vertically, followed by serious winds and subzero temperatures, I can only think that those daffodils are sorry now. Especially given a forecast calling for more heavy snow.

But we continue to look on the bright side and are comforted by the fact that Daylight Savings is now only 16 days away.  Yep. And in the meantime, here is a bit of what happened this week that was noteworthy:

  • Approval of First DTC Genetic Test - FDA made two announcements in one this week when it issued a release regarding the fact that the agency was clearing for marketing the first direct-to-consumer genetic test so that a person could determine if they carry the gene variant for Bloom syndrome. The announcement is newsworthy in many respects – first and most obvious being the approval itself. Also within the announcement, FDA also stated that it was minimizing the regulatory pathway for the device by making it a Class II designation and exempting these devices from premarket review. According to the company release, test results will not be available until the company “completes the regulatory process for additional test reports and can offer a more comprehensive product offering.”
  • Scientific Report of Dietary Guidelines CommitteeHHS announced this week that the 2015 Dietary Guidelines Committee had released its scientific report which forms the basis for this year’s guidelines. The report has been making many headlines on what is good and what is bad in our diets with the perennial news that what we are doing is not working very well – we are getting low intakes of key food groups and too much in the way of sugar. The Executive Summary can be found here.  Obesity is prevalent. Comments can be submitted through April 8 here.
  • FDA Approves Closure System to Treat Vericose Veins – The VenaSeal Closure System was approved by FDA this week for the treatment of vericose veins by sealing the affected superficial veins with an adhesive agent, the first treatment to do so, providing a new treatment option for the condition.  FDA reviewed the premarket application as a Class III device.

That’s it for me this week folks.  I think it is a good weekend for French Onion Soup and fireplaces and good books indoors.  Take care.

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The Language of Risk – FDA’s Evolution of Thought

How does the average patient assess the risk of a medical product when deciding whether or not to seek it out?

This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drug Products” which revised a 2004 draft guidance – “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements“.

Regulations require that when companies produce promotional materials that the risk information be included.  This was referred to as the Brief Summary. To fulfill this requirement, manufacturers often included the entire risk related sections of the package insert – which could be lengthy and which are written at a very high level of medical understanding which the agency has come to conclude was not of great utility due to the fact that patients/consumers were really not that likely to read, consume and understand the contents. In addition, the information included was voluminous, containing a good deal of detail. Therefore while it technically complied with regulation, it did not meet the objective – which was to inform the patient/consumer.

With the revised guidance, FDA provided new thinking on the “Consumer Brief Summary” – creating a pathway for risk information to be presented in a more consumer-friendly method with more relevance and less detailed information by focusing on the most important information and leaving out the exhaustive profile of the risk.

FDA believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers. Thus, FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements, an approach in which risk-rlated sections ofthe PI are presented verbatim, often in small font….Furthermore, the risk information int he PI sometimes includes lengthy lists of all possible adverse events. In general, FDA believes that exhaustive lists that include even minor risks detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks.

The draft guidance is specific to prescription drugs, but appears to reveal an underlying shift of thinking by the agency to which we were perhaps given a prelude when the agency released its draft guidance “Internet and Social Media Platforms with Character Space Limitations – Presenting Risk Information for Prescription Drugs and Medical Devices” in which FDA enunciated the policy that the most important and essential risk elements could be profiled in linked material, but that the platform in which there was a character-space limitation (for all intents and purposes – a tweet or an online advert) could make reference to the material deemed most pertinent, i.e., contraindications, boxed warnings, etc.

In the new guidance, FDA makes clear that it will not object if a firm does not include “each specific side effect and contraindication” from the package insert (PI) and then lays out the pathway by which a firm can supply risk information without the full PI which in part, includes:

  • Avoiding medical jargon and devise reading level to apply to large consumer population;
  • Using headlines and subheadings to denote important information;
  • Information addressing the following should be included:
    • Boxed Warning
    • All contraindications
    • Certain information regarding Warnings and Precautions
      • the most clinically significant information from the Warnings and Precautions sections of the PI
      • information that would affect a decision to prescribe or take a drug
      • monitoring or laboratory tests that may be needed
      • special precautions not set forth in other parts of the PI
      • measures that can be taken to mitigate or prevent harm
    • Most frequently occurring adverse reactions
    • If a product has more than one indication, then it should be included for each indication, even if the promotional material is limited to a particular indication and listed in the same order as the PI
    • Clinically significant drug interactions

Because the information that will be presented in this new version will not be comprehensive, FDA wants this Consumer Brief Summary to include reference to that fact and to link the consumer back to the fuller information. The guidance also provides suggestions for formats for the new information. (Note, this is not a comprehensive overview of the requirements contained in the draft guidance and all are encouraged to read it in its entirety.)

One may wonder what impact, if any, this guidance may have in other areas of promotional speech. It is reasonable to assume that given the guidelines contained in the draft guidance on character space limitations and in this guidance that FDA is moving down a path whereby abbreviated versions of risk information are, under select circumstances, acceptable and even at times preferable. Time will tell.

With respect to this particular draft guidance, the comments section is currently open. It remains to be seen how this guidance will be put into place once comments are considered. It does not appear that comments have so far been received. Also how FDA’s OPDP enforcement – which has been on a low volume scale – chooses to further clarify FDA’s outlook on what information gets included in what type of format.

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Weekly Roundup 2.13.15

Happy Friday the 13th and the day before Valentine’s Day. It is cold.  There is fierce wind. Boston is due more snow. As if there aren’t enough reasons to dislike February….

For me the week flew by and I hope your’s did as well.  Here is a little bit of what happened that caught my eye as I work on a few things for next week:

  • Thyroid Cancer Approval - Continuing the pattern of last year, FDA approved another drug under priority review this week, this time a kinase inhibitor called Lenvima which is indicated for differentiated thyroid cancer (DTC) for patients who have seen their disease progress despite the fact that they received radioactive iodine therapy. FDA states that DTC is the most common type of thyroid cancer. The company recently announced the Phase III study results published in the New England Journal of Medicine.
  • OPDP Issues First Regulatory Action Letter of the Year – OPDP issued the first Untitled Letter of the year this week, continuing a trend that seems to have taken hold where the division is putting out guidance via regulatory action letters in a trickle, and seems usually aimed at smaller companies. The letter involved the production of a video and the violations cited included minimization of risk, lack of adequate directions for use, omission of material fact and a misleading claim. On the misleading claim, the statement cited was regarding the impact of the product on the well-being of a patient.  Characterizing patient outcomes in video, as written many times here, can easily convey an impression that is outside of what is written in the label.
  • FDA Sets Second AdComm for Biosimilar Product Consideration – A meeting of the Arthritics Drugs Advisory Committee has been scheduled for March 17 to consider a BLA application for another biosimilar – this time for the reference product Remicade® (infliximab) submitted by Celltrion. As noted in an earlier Weekly Roundup at the beginning of the year, the first advisory committee meeting was held to consider a biosimilar application and unanimously voted to recommend approval. It appears the stage is set for a new era of biosimilars in spite of outstanding policy/regulatory questions.
  • FDA Issues Round of Guidance and Policy Docs on Compounding – For some time, FDA has been putting into place the structure around the agency’s newly acquired authority over compounding. On Friday the agency issued four new draft guidance documents and provided an example of a memorandum of understanding between states and the agency. You can find all of the documents in the FDA’s press release on it and the Compounding Tab at the Eye on FDA site has links to all these and more related to the issue.

That’s it for me this week folks.  Stay warm and well. And have a good weekend.

Note:  After original publication on February 13, 2015, this posting was modified to add the later-breaking news of the compounding documents.

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