Envisioning 2.0

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.

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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.
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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 »

A couple of quick notes about the continuing Plan B story this morning.

First, John Mack over at Pharma Marketing Blog takes a look at how Barr might leverage the Internet to market Plan B to consumers. He mentions that the company may engage in “behavioral targeting” to advertise the product to potential users. I’ve discussed behavioral marketing here, which has many pitfalls. Still, Mack’s idea is interesting and deserves some thought.

Second, the New York Times reports that Barr does not expect Plan B to be a blockbuster. It will earn about $60 million at best. Barr says that producing the product will solidify its reputation in women’s health. An analyst scoffed at this notion, saying that most women won’t know where they are getting the product from.

Could producing Plan B do good things for Barr’s reputation? It’s hard to say. Women will be aware of the controversy surrounding it, but will they know that Barr developed the medication? Will they care? Only time will tell.

The FDA announced today that it has approved the use of the oral contraceptive Plan B for limited use by women 18 years and older.  According to an FDA press release, Barr has agreed to implement the CARE (Convenient Access, Responsible Education) that will:

- Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

- Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;

- Packaging designed to hold both OTC and prescription Plan B.  Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

- Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Learn More
- Click here to read a Wall Street Journal story about the FDA annoucement.

- Click here to access the FDA Web site focusing on Plan B.

- Click here to read an article recently posted on this blog about the Plan B issue.

The FDA announced that sales of over-the-counter (OTC) Plan B could begin in weeks.

According to the New York Times:

“The drug agency has asked that the new Barr application restrict over-the-counter sales to women older than 18. Girls younger than 18 would have access to the pills only with prescriptions. Over-the-counter pills would be sold just in pharmacies and licensed clinics, the chairman of Barr, Bruce Downey, said.”

See this article for commentary on the FDA’s recent Plan B moves.