Envisioning 2.0

Recently, the FDA launched a taskforce and blog designed to make the agency’s decisions more understandable and open to the public.

This is a good move.  The FDA has been under incredible fire in recent years around how it decides to approve drugs (Are politics rather than science influencing decisions?), how it regulates drug marketing, its advisory boards and other issues.

This is a great first step for the agency.  So, if you’re concerned about the FDA and want to help make it more transparent, go over to the blog and make your voice heard.

Story Source: Pharma Blog Review

For many years, pharmaceutical companies and advertising agencies have been producing text advertisements that link to Websites promoting medications.  Generally, advertisers used what what was dubbed the “one click rule” – i.e., if information about the risks associated with a medication was included via a hyperlink, they would be fulfilling requirements to post information about prescription medication side effects.

No more.  Recently, the FDA issued 14 warning letters to various pharmaceutical companies demanding that they start including risk information in text advertisements.  According to the New York Times:

“When the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.”

Today, attendees at a panel with the FDA at the Direct to Consumer National Conference expressed disappointment (via Twitter) that the FDA was not more forthcoming about the warning letters.  In addition, Peter Pitts who is working for the Public Relations firm Porter Novelli said (in a comment he left on the Wall Street Journal blog):

“Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.”

Ken Johnson, senior vice president at the industry trade group PhMRA had this to say: “Rather than regulate through warning letters, FDA could help patients and serve the public health by initiating a public dialogue and FDA guidance outlining clear standards.”

While industry executives are perplexed by the new warning letters, one can look at this situationa as a glass half full.  Demands on the FDA to issue clear and unabigious guidance on Internet and social media marketing will only increase.  I understand that people inside FDA are open to dialogue.  In my opinion it can’t happen fast enough.

Today, my e-mail box has been burning up with astounding news from the FDA regarding social media marketing.  In a press release, which is starting to be widely distributed online, the FDA is said to be developing draft guidance on social media marketing! First, my mouth fell open in shock.  Then I remembered what day today is, April 1.  Here’s the “release”:

“New FDA Draft Guidance Aims to Improve Health Information Obtained via ‘Social Media’ Websites

The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on ’social media’ Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program (see http://tinyurl.com/d3lvag).”

This is a clever ploy by my fellow blogger John Mack of the Pharma Marketing Blog to drive traffic to his Website and get folks buzzing about the new “guidance.”

I took some time to call one of my contacts in the FDA’s media relations department today about this release, Rita Chappelle.  She is aware of every FDA release that crosses the wire.  She told me: “We have not issued any releases today.”  Check out the FDA’s newsroom to confirm her statement – as of 1:30 p.m., Eastern.

Also, careful examination of the “release” reveals that the telephone number listed regarding media contracts is incorrect.  In addition, FDA always provides specific contacts on all releases who can field media requests.  Finally, the FDA does not use TinyURL links in its official communications.

So, stop distributing this release to your colleagues.  You’ve been had.  April Fools!

It’s been a wild, wild few weeks at the Food and Drug Administration. Since Andrew von Eschenbach took the helm, the agency has engaged in a number of defensive moves designed to assuage critics and pre-empt Congressional action. However, the agency can’t seem to catch a break as observers on all sides pan the FDA’s actions. In addition, von Eschenbach had to backpedal after he made remarks that seemed to indicate he would punish FDA officials who went around the system. Take a short ride on the FDA rollercoaster with me as I highlight some recent agency-related events.

Read the rest of this entry »

After months of political wrangling the Senate confirmed Andrew von Eschenbach, MD as the head of the Food and Drug Administration last night. His ascension to the top spot at the agency comes at an opportune time as it faces a number of very difficult challenges.  Some of the most important include:

-    Expanding the FDA’s budget given the raft of additional regulatory duties it is being asked to take on

-    Streamlining and improving the review of direct to consumer advertising/marketing

-    Managing conflicts of interest on FDA advisory panels

-    Monitoring the safety of medications after they have been approved by the agency

-    Determining whether and how to develop a generic market for biotech drugs

Look for von Eschenbach to appear at a number of Congressional hearings on these issues next  year.

An interesting Wall Street Journal article published today reveals some interesting information about the ongoing debate at the FDA over the testing and use of new antibiotics.  According to the Journal:

“An unusual clash among officials at the Food and Drug Administration is highlighting a dilemma: The FDA wants to make sure that drugs work before approving them, but it also faces pressure to be flexible and encourage the development of badly needed new antibiotics.

FDA officials battled earlier this year when deciding whether to approve the antibiotic Cubicin for heart-valve infections. Staff reviewers urged their boss to say no, citing ’serious misgivings’ about the drug’s effectiveness in the disease, according to documents reviewed by The Wall Street Journal. The head of the agency’s division for anti-infective drugs overruled the staffers, defending the drug and saying doctors need more weapons against dangerous bugs.

Behind the debate is growing concern among doctors about the rise of bacteria resistant to antibiotics. They want more investment by drug makers in the field, but many companies are hesitant. An antibiotic used for a day or two is far less lucrative than a pill that a patient might take daily for decades. What’s more, powerful antibiotics are sometimes kept in reserve for the most serious cases, which diminishes their commercial value.”

Look for this debate to intensify as the FDA stuggles to come up with new guidance on antibiotic clinical trials and encourage pharmaceutical companies to develop new drugs.

Over recent months, the FDA has been focusing heavily on antibiotic safety, efficacy and clinical trials. Today, the New York Times reports that the FDA has asked an outside panel of experts to evaluate the safety of Ketek, a powerful antibiotic that has been linked to liver failure. The panel meeting will take place on December 14 and 15.

The FDA’s announcement comes after the Senate Finance Committee announced plans investigate how the agency handled the approval of the Sanofi-Aventis drug in 2004.

Regardless of the outcome of the panel’s investigation, it is clear that the FDA’s stance on antibiotics is changing. To learn more about this issue, please see the following posts on this blog:

- Antibiotics, Clinical Trials & More: An Interview With The FDA’s John Powers, MD

- Consumer Driven Healthcare: The Good, Bad and Money; FDA May Be Changing Tune On Antibiotic Trials

We all know that when it comes to communications, actions speak louder than words. For those who have accused the FDA for caving in to the pharmaceutical industry and approving unsafe medications, new data compiled and published today by the New York Times belies critics’ assertions.

According to the Times:

- Only 1 out of 14 drugs submitted for approval during fiscal year 2005 were cleared by the agency during initial review
- It is getting tougher to get medications similar to those already on the market through the FDA – especially if they have side effects
- Drugs for diseases like cancer are receiving fast-track review and approval by the agency.
Read the rest of this entry »

In an extensive interview published in the September edition of Pharmaceutical Executive, Senator Charles Grassley, a long-time critic of the Food and Drug Administration (FDA), blasts the agency for putting patients last and pharmaceutical companies first. Following are some of his more biting comments.

- The FDA Is More Worried About PR Than Patients: “There is a culture within the FDA that’s more worried about its public relations than it is about patients. Now I can say the same thing about the FBI, and I have. It may not just be an FDA problem, but a culture problem in all government. You see it, for instance, when the Office of New Drugs approves something, and the Office of Drug Safety raises questions about it. The Office of New Drugs doesn’t want egg on its face, so it tries to squash the controversy.”

- The FDA Is Too Cozy With Pharma: [I]t seems to me, the relationship between FDA and pharmaceutical companies is too cozy. We see evidence of this in some of the telephone notes and e-mails we’ve had access to. It’s just not right. The only person that should be across this table from the FDA is John Q. Public. It seems like FDA officials see themselves too much as facilitators working with the drug companies—instead of regulators.

- Drug Ads Don’t Effectively Communicate Drug Side Effects: “I’ve watched so many of these commercials and feel that the dangers [of drugs] are not as obvious as they ought to be. When the person presenting the commercial gets to the lines about safety, they go very very fast. It just seems to me that that compromises the safety issues of some drugs. And so I’m not looking at it from the standpoint of whether there ought to be drug advertising or not. I’m looking at it from the standpoint of it being effective advertising regarding drug safety. We have asked the Government Accountability Office to examine DTC advertising on safety issues. A report should be out early next year.”

(The current edition of Pharma Marketing News features a very interesting analysis of risk vs. benefit information in print DTC ads. It’s worth a read. Click here to access the article.)

Click here to read Grassley’s remarks. I’ll be focusing on the topic of the current communications enviornment faced by the FDA in the next edition of my firm’s newsletter, Envisioning.

This is the last major article in an ongoing series on this blog titled: “The FDA and the Pharmaceutical Industry.” Posts filed under this category focus on the intersection and relationship between the agency and drug companies.

A few months ago, I conducted an interview with Dr. John Powers, Lead Medical Officer for Antimicrobial Drug Development & Resistance at the FDA. During this wide-ranging discussion, we talked about a number of important topics, including efforts to curb the spread of antimicrobial resistance, the drawbacks of non-inferiority trials and FDA advisory boards. Powers’ extensive commentary appears below. Read the rest of this entry »