AdComm Recommendations – How Often FDA Does Not Follow Them?

When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the meeting, the individual members read and review large briefing books. In addition, FDA staff have pored over materials and provided their opinion.

The day almost always goes the same in terms of agenda. The sponsor makes out their case and presents it. FDA presents their own findings. The public can provide comment during an open public comment period. Ultimately, the panel is called by FDA to answer a series of questions that are designed to provide advice on aspects of the drug application to help the agency in making an ultimate decision about approval. At or near the end of the day, the committee deliberates and votes yea or nay on one or more of the questions. Usually within a few months of that FDA announces a decision to the drug sponsor.

They are called advisory committees for a reason. They are there to provide advice. Advice, as we know, may or may not be followed. How often does FDA go against the advice of its advisory committees?

I went back to 2011 and looked at every advisory committee meeting and found that there had been a total since then of 231.  Of those 145 of were held to consider a treatment candidate for approval. Of those 145, decisions have been reached in 136 of them while the balance are still under consideration.

What is the track record of recommendations for or against approval?  It may surprise you to know, as it did me, that FDA Advisory Committees offered negative assessments and voted not to approve a drug 30 percent of the time (41 meetings). They voted to approve the drug 70 percent of the time (95 meetings).

So if a new drug application gets approved by the advisory committee, what are the chances that FDA will act against the recommendation?  Since 2011, I found that there were 7 times that a panel had voted against approval of a product where FDA went ahead and gave the product an approval. And I found that there were six times that panels recommended approval, but FDA decided not to do so.

In the aggregate that means that about 10 percent of the time overall – at least using meetings since and including 2011 through 2016 FDA decides ultimately on a different course than was recommended by its advisers. So next time someone asks the question, you have an answer.

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Weekly Roundup 7.29.16

The lawn is a lovely shade of brown. What can one say after that? The hot, humid days always evoke for me very strong childhood memories when the days were long and the season far too short and time was spent by swimming pools and on long morning bike rides. And the season figures prominently into some of the news of the week as well because along with everything else, it is mosquito season.

  • FDA Asks Some Counties in Florida to Halt Blood Collection Due to Zika - Until recently it had appeared that the only cases of Zika in the continental U.S. had occurred among people who had traveled in areas where the virus has proliferated or due to sexual transmission. This week that changed. FDA announced this week that the agency was taking “important steps” with respect to Zika control by asking some specific counties in Florida to cease collecting blood donations until Zika measures could be put into place through the use of investigational testing or inactivation technologies. This came after Florida health officials announced that they were conducting an investigation into non-travel, non-sexually transmitted cases of Zika in Miami-Dade and Broward Counties suggesting the possibility of local transmission. This is a story to watch well beyond the boundaries of summer.
  • CMS Issues Star Rating System for Hospitals – Generally speaking, as patients, we blindly go to whatever hospital that is nearby. In some rural areas, there are few choices. We are little informed by anything other than the word of mouth experience of others, online reviews or opinions shaped by what we have read in the newspaper. Now CMS provides you with the ability to see not only the strengths and weaknesses of a particular hospital across multiple categories of assessment, but to compare hospitals in your vicinity vis a vis one another to see how they stack up. Having used it, let me assure you that the results can be quite eye-opening, particularly if you are in an area where your choices may be few. You can search by zip code or by specific hospital name. When you search, you don’t just get a little information – you get a lot across a spectrum. You can check it out here.
  • FDA Opens an Ear About HIV and Blood Donation - This week the agency announced that it was opening up a docket to accept public comment about blood donation and HIV. The existing policy came into scrutiny as a result of the tragic Orlando mass shooting that occurred in a gay bar in which scores of people were not only killed but many left wounded and in need of blood. The irony was noted widely that under existing FDA policy on blood donations and gay men, most would be barred from donating blood needed for transfusion purposes. The agency last updated its guidance on the topic in December 2015 to reconsider the total ban that existed to one that was time based. Now the agency will consider an approach that is based on individual risk assessment. Comments in the docket can be filed here, and as of this writing there have been 44.

That’s it for me this week folks. Have a wonderful weekend. August is coming!

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Weekly Roundup 7.22.16

Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I may cover this week, came from last, but was really interesting and so we are including it here. I am liable to be just as dull in August.

That said, there were some things of note:

  • Advisory Committee Recommendations and the Psoriasis Landscape – Two different AdComms were held that were of note. In meetings of the Arthritis Drugs Advisory Committee on the 12th and 13th, it was recommended that two new biosimilars be recommended for approval for several indications held by the reference products.  If these are both approved by FDA it would double the number of FDA approved biosimilars. Both applications sought approval of multiple indications, one of which included treatment for moderate to severe plaque psoriasis and both had unanimous approval of the committee.  And in a related development, another biologic that sought approval for the treatment of moderate to severe plaque psoriasis received a recommendation of approval during a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee on June 19, also with unanimous approval.
  • Advisory Committee Calendar Light on NDA Deliberations – On a related note, right now the FDA calendar of upcoming advisory committee meetings has six scheduled during the balance of July through October, but only one of these is to consider a new product for market. As noted in a recent posting about FDA press releases, fewer approvals have been announced by FDA this year compared to last year’s banner year of approvals. Not every drug has an advisory committee hearing, but it nevertheless is one of the indicators about the approval rate moving forward. It could certainly change in the remainder of this year, but the limited and early indications are that this year may not meet the level of last year’s approvals.
  • HIV Developments – The International AIDS Conference was held this week in Durban, South Africa. It is the second time the conference has been held there and the first time was not long after the introduction of anti-retroviral therapy (ART). At that time, the challenge was to get people treatment with ART as a means to save their lives – a goal that is still a work in progress. Since then the role of treatment as a prevention has emerged with important data published in the New England Journal of Medicine - Antiretroviral Therapy for the Prevention of HIV-1 Transmission. On a related note, NIH announced this week that it was expanding investment into basic medical research aimed at a cure for HIV.

Stay as cool as you can this weekend and take care.

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More or Less – A Look at FDA Press Releases at Half Year

What do FDA press releases for the year say about the rate of new approvals for 2016?

Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I provided an overview of the first quarter look at the press releases sent out by FDA. What we saw then was announcements of approvals – both for devices and drugs – were down from the previous year. As we cross the mid-year mark, it is time to update and see where we are in terms of FDA pronouncements.

It is important to note here that official announcements of FDA approval actions are just that – not every approval gets a press release. By my observation, they are generally focused primarily on matters that are noteworthy because they are just that – and this year have included a number of compounds that have had one or more of the following – breakthrough therapy designation, priority review status, accelerated approval and/or orphan drug status. You don’t usually see releases for drugs that are fifth in class, unless they bring something new to the table.

Here is an overview of letters comparing the first six months of approvals for the years 2013-2016.

The purple line at the top shows us the total number of press releases for the first half-year period of each year from 2013-2016. One can see that while there were more in 2013, the past few years appear relatively even, though slightly under the past few years.

However, when looking at the green line which denotes combined approval announcements (drugs, devices, and other -which includes tobacco, apps, food-related approvals), at 32 total approvals (drug, device and one in food) the number for the first half of this year was down quite a bit from last year, when FDA had a banner year of approvals of new molecular entities.

Both drugs (signified by the red line) and devices (signified by the blue line) are down, however, the drug approvals experienced a greater drop than did devices. By mid-year last year there were 28 new drug approvals compared to 19 so far in 2016. That said, when you look back to last year’s banner year of approvals, the bulk of the new drug approval announcements occurred in the second half of the year (47).

The other categories tracked – legal actions such as consent decrees, recalls and public health alerts and general announcements were all at similar levels to years gone by , though the issuance of new policy through rules is higher, with 14 issued so far this year, compared to only 7 at this time last year.

Again, approval announcements are not the same as approvals – many approvals have no FDA announcement. But using the press releases as an indicator of the current approval rate of new molecular entities, unless the second half of this year follows the same pattern as last year, there may be indications that 2016 is not the banner year in approvals that marked 2015.

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Weekly Roundup 7.8.16

Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer is well along when in my  mind, the buds have just pushed and daffodils were in bloom. July 4th came and went already when it seems like we just had Memorial Day. Before you know it, we will be back to school.

You may still be away from the long Fourth of July weekend or enjoying a shorter work week if you are back. Just prior, a lot happened last week and some this and since there was no Weekly Roundup last week, we are coving two weeks.  Here is some of what I found interesting:

  • FDA Launches Oncology Center of Excellence – Both public and private institutions are in the process of responding to President Obama’s “Cancer Moonshot” announced in this year’s State of the Union message and headed by Vice President Biden. The gist of the effort is to better coordinate resources focused on cancer treatment and research to effect outcomes more quickly by concentrating efforts across the board. As part of its response this week FDA named Dr. Richard Pazdur as the Acting Head of FDA’s Oncology Center of Excellence (OCE). According to the agency release, Dr. Pazdur will be working to bring closer collaboration across the FDA centers (devices, biologics, drugs) to develop greater coordination and review of new advances. In his blog posting on the topic, Dr. Pazdur also stressed that the effort will also engage outside FDA as well, ensuring that patients have a voice. Many aspects of Dr. Pazdur’s professional experience and personal life went into the choice. While often FDA communications are in FDA-speak, you can read a very nice 2016 New York Times article about him here.
  • FDA Chips in to Move the Needle in Precision Medicine - In his 2015 State of the Union message President Obama launched the Precision Medicine Initiative aimed at speeding up the process by which we would be able to deliver therapies for patients that are determined to be the right ones rather than treatment by trial and error. Fundamental to success in that goal is the development of genetic testing. There are many moving parts, but this week FDA added a contribution with the announcement that the agency was issuing two guidance documents to provide a “streamlined approach” for oversight of genetic testing. According to FDA’s release, new sequencing technologies will allow for the examination of millions of DNA variants at a time, rather than taking a more piecemeal approach.  NIH urged researchers to adopt the best practices outlined in the draft guidance documents which the release states were developed to enhance test development while maintaining safety. The two draft guidance documents can be found here and here.
  • Zika, NIH and the Olympics – A lot is being written, and a lot more is likely to be written, about Zika and the upcoming Olympics in Brazil. This week NIH announced that it was funding a Zika study of the U.S. Olympic team to monitor potential infections among them. The stated goal of the study is to better understand how the virus persists in the human body as well as to identify personal factors that may influence the course of the infection. In another Zika development, FDA announced an Emergency Use Authorization for an In Vitro diagnostic device for use in the detection of Zika virus.

There is more of interest, but that’s it for me this week folks. Next week I will provide you with an update on what FDA had to say during the first half of 2016 and how it compares to other years. Until then, have a good weekend!

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