Eye on FDA

As Storm Clouds Gather....

There is little doubt that the pharmaceutical and biotechnology industries are in for a tough time in the coming months through the election cycle and beyond.  The breadth and depth of investigations and inquiries coming from Capitol Hill, by members of both parties, certainly signal significant reform.  In the meantime, as a prelude to that reform, lawmakers will be looking for any means at hand to haul expose failures and shortcomings.

Polls released today in the Washington Post make it appear that the Democrats are poised to make hefty gains in the Congress this fall.  Eight out of ten American say we are on the wrong track.  And for eight years, Democrats have felt a drift in regulatory enforcement across the board, and many with FDA in particular.   And whichever of the remaining three candidates win the presidential election, all three favor Medicare Part D reform to allow the government to negotiate prices and the importation of drugs. 

The process of reform will bring added scrutiny in the coming months and industry reputation, as well as individual company reputations, will be tested.  My brilliant colleague Mary Curtin has put together some excellent points in this regard and I've added a few of my own:

• Ask the really hard questions now that run the entire range of topics up for reform discussion - from DTC to the timely conduct of Phase IV trials;
• Once you've anticipated the hard questions and line up your spokespeople and internal protocols on a range of subjects now.  Don't wait.
• Conduct an internal assessment of vulnerabilities and issues;
• Monitor the blogosphere.  You can monitor blogs, you can even monitor twitter and YouTube.  New media offer the first glimpse into where public opinion is going on a whole range of topics.  Don't confine your assessment of trends to mainstream media anymore.
• Assess your attributes, such as plans for good, sound studies that benefit the public interest, particularly around pharmaco-economic data.  If you don't have any planned, consider it.
• Consider partnerships that again demonstrate the role of  the company in areas of public interest.
• Don't assume people understand the depth or breadth of your company's philanthropy. 

These are all sound bits of advice for near-term strategic communications and business planning given the way the current environment is developing.  Go to it. 

Weekly Roundup - 05/09/08

It is raining buckets - reportedly 3 inches since yesterday.   The water table looks like its headed for restoration here.   Lots of thunder and lightning.  Flood AND tornado watch.  Congress is skipping town to go home to Mom.    Other than that, a quiet time here inside the Beltway.

And here is a little of what went on this week:

• House Committee on Energy and Commerce holds hearing on DTC advertising -  It was the Subcommittee on Oversight and Investigations and to give you a flavor, here is what Congressman Dingell had to say - "Regrettably, investigations by this Committee have revealed systematic violations of these principles by a number of drug companies. Some ad campaigns have been misleading and others appear downright deceptive."  Or, if you want to see the whole Webcast, here is a link to the hearing - I had trouble accessing.  Look for lots more action on this front in months to come.  Hearing coverage made ABC World News Tonight.  It also got widespread national media coverage across the board. 
• And the Subcommittee on Health Holds Hearing on Stem Cells - And a flavor of this hearing from Congressman Dingell - "None of us can guarantee to those suffering from Parkinson’s disease, spinal cord injuries, or multiple sclerosis that embryonic stem cell research will bring success. But we can guarantee that if we let politics, not science, guide our efforts, we consign ourselves to failure."  - As the Congress shakes the yoke of this Administration, look for lots more action on this front as well.
• Astellas Gets Euro Nod for Mycamine - This was interesting since there have been a host of drugs that have gotten European approval, but are held up in the U.S., Astellas got approval for an antifungal in Europe which has been approved in Japan since 2002 and the U.S. since 2005.   The company reported in its release that it received approval in late April, though announced it on May 7.   The indication is for invasive candidiasis. 

That's it for me folks.  Have a good weekend everyone.       

DTC in the Crosshairs on the Hill

The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations held a hearing this morning entitled "Direct-to-Consumer Advertising:  Marketing, Education or Deception?"  This is further evidence that as the election cycle heats up the Congress is quite likely to endorse legislation that would fundamentally change DTC and other pharmaceutical marketing practices, and that the scrutiny of same will endure for months to come.

The witness list included Dr. Ruth S. Day, Director Medical Cognition Laboratory at Duke University and a former member of the FDA's Drug Safety and Risk Management Advisory Committee, as well as representation from the American Medical Association, the Kaiser Family Foundation, the Government Accountability Office, as well as several members of industry.

It is a gloomy day in Washington, and I expect a bit stormy up on the Hill. 

FDA Issues Another Approvable Letter

This time, the letter was directed to Astellas, and it isn't the first one.

According to an Astellas press release that was issued today, the company stated that it received an approvable letter for its NDA for FK 506 Modified Release formulation - an immunosupressant for the prophylaxis of organ rejections in patients who receive liver transplants.  FK506 is a once daily formulation of the existing product Prograf (tacrolimus). 

No FDA reasoning for the approval letter was stated by the company.

This is the second approvable letter that the company has received for this product for this indication, having gotten one in January 2007  13 months after filing the NDA in December 2005.  After submitting a response in July 2007, the company received the second approvable letter April 30, 2008 and announced its receipt today.

The company also states in the release that it received an approvable letter for once-daily Prograf for use in kidney transplantation in January 2007 and again in March 2008 and got a not approvable letter for use in heart transplantation, also in January 2007. 

Weekly Roundup - 05/02/08

I am having a great deal of trouble wrapping my head around the fact that it is May, but look out the window and there it is.  Inside the Beltway, we start counting down to the next Congressional recess, so that those guys get out of town, making less news, less trouble and less traffic.  It was a very busy week here, and these are a few of the things I thought interesting:

• Lots of Testimony - The FDA was up on the Hill twice this week and the agency was really good about quickly posting the testimony to the Web site.  First of all, yesterday Dr. Janet Woodcock delivered "Discussion Draft Of The ‘Food And Drug Administration Globalization Act’ Legislation: Drug Safety" before the House Committee on Energy and Commerce, Subcommittee on Health and the statement made by John Dingell extended gratitude that FDA appeared to be getting specific about authorities and needs.   A few days before, Dr. Woodcock was again delivering testimony, this time before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations - this time on the Heparin issue.   Perhaps Dr. von Eschenbach is seeking to leverage her credibility in the Congressional venue, which isn't a bad thought, but it does cede authority over very important matters to someone who is not in charge of the agency, only one division. 
• Consent Decree Signed - Ouch.  Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.  According to the press release by FDA, FDA inspections conducted in October 2006 and January 2008 revealed cGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions. These deficiencies do not necessarily mean that the defibrillators currently on the market will harm patients, but FDA is requiring corrections to ensure the continued availability of safe, effective, and reliable products.  Note that previous FDA inspections in 2000, 2003 and 2005 showed similar violations. FDA issued warning letters after the 2000 and 2005 inspections, citing the cGMP violations.If you are interested, harken back to my earlier posting called Anatomy of a Consent Decree.
• Approvable Letter Issued to Discover Labs - The company announced today that it received an approvable letter last evening from the FDA for Surfaxin (lucinactant), an investigational treatment for premature infants suffering from Respiratory Distress Syndrome.  The tone of the company's press release seems to convey surprise at the action.  The stock (DSCO) closed at $2.90 yesterday and this morning as of this writing has lost almost half its value, trading around $1.49.

That's it for me this week.  I'm off for a weekend of gardening, bike riding and raw oyster eating.   

Most Recent Heparin Hearing

Here is some footage of the Heparin meeting from this week where it was stated that the contamination of Heparin would appear intentional. 

Note: If you are a subscriber you will have to visit the Eye on FDA site to view.

When it All Goes Bad - Crisis Communications During Tough Times

We all have a bad time of it some of the time.  Sometimes a confluence of events just throws us off our game.  It isn't just one bad piece of news, it is one after another and your very character is threatened not just by each and every challenge, but by all the challenges.  I hate it when that happens. 

Consider the situation of Merck over the past several weeks, this month in particular:

• The ENHANCE study on Vytorin cast doubt on efficacy - timing of study release questioned by many as opportunistic;
• FDA announces investigation into suicide and use of Singulair, announced March 27
• Senator Charles Grassley sends letter to Merck demanding to know marketing details for Vytorin in the wake of the ENHANCE study to examine promotional efforts after knowledge of study results was in hand; 
• On April 11, Congressmen Dingell and Stupak issue release expressing "concern" over timing of the ENHANCE announcement and indicating that investigation begun in January 2008 is "far from over";
• JAMA publishes study of Merck practices respecting ghostwriting of studies, April 16
• An April 28 Warning Letter is issued to Merck for cGMP issues;
• The FDA rejects an application for approval for a combination product of Singulair and Claritan (involving the same two companies that produced Vytorin);
• The FDA rejects a Merck NDA for its new cholesterol medication Cordaptive - sends non-approvable letter;
• Merck stock plunges in wake of rejection of Cordaptive and analyst lower their targets for the stock.

Each of these issues is serious when considered as a stand alone proposition. 

But together, they will draw the credibility, intentions and core competencies of an entire company into question among multiple key stakeholders.  Together the issues cause scrutiny of a company's culture.  And while each and every crisis demands a communications response, more than that, when taken together, the situation demands a communications plan not only in response to each and every crisis, but in response to the crisis that is happening because of the sheer magnitude of things gone wrong. 

When a company that faces this kind of pressure, a crisis playbook becomes essential.  It is complex communications plan that must be comprehensive in both scope and nature and have breadth and depth.  It is multidimensional and looks back as well as forward.   

In it, a company must consider both the internal and external audiences.  It must provide messaging that is aimed at employees and the sales force as well as the investing public, policymakers, regulators and customers.  And it must deal with each and every crisis as an individual crisis as well as dealing with the totality that is involved by the sheer weight of the totality of the situation.

I always think crisis opens up a window of opportunity.  Crises make us new people as individuals, the same can be said of companies, and while going through a crisis is no fun, what comes out on the other side, if managed well, can be better.   

 

I Lived in Hollywood for 10 Years!

It's true. (I hated it)

And yet I have apparently committed the ultimate shame!  I have misquoted a classic film or at least mis-attributed the quote. 

I have been informed by numerous emails that it was NOT Paul Newman who uttered that famous line, but Strother Martin - which actually was a bit in my recollection of the film, but I went with a crummy internet search I did. 

Boy, you guys, I don't hear this much from you about FDA stuff, but get a quote wrong, and EVERYONE emails me! 

We should all get together for an Oscar party!

No posting today because I was at a meeting all day long in Maryland.

I stand corrected, though you have to admit, it was a Cool post!

Get Help on Communications!

"What we have here is a failure to communicate."  These words were spoken by Paul Newman in the classic film - Cool Hand Luke. 

Well, he's no Paul Newman, but the words perhaps apply to the FDA Commissioner.  Yesterday the Washington Post ran an editorial, the second in the past several weeks, about the FDA entitled "The FDA Needs Help" - stating that "[t]he heparin scare revealed problems the agency says it can fix.  But it won't tell Congress how much that will cost."

That is a problem.  And, one that was noted last week by Congressman John Dingell, Chair of the House Committee on Energy and Commerce who said in a statement about this very topic: 

"The last time the Commissioner of Food and Drugs was here, he promised to return and give us the details of how he was going to fix this mess. I hope that his testimony will not resemble what he told the Senate Appropriators last week, which appeared short on substance and heavy on bureaucratic buzzwords. "

The agency is truly in a communications crisis regarding its status with policy makers.  Last week, the agency was criticized for hiring a public relations firm which was deemed a "luxury" by critics.  The agency and the public relations firm cited both denied that it was true.  Would that it were.  In the case of the FDA, learning how to better communicate, particularly when it comes to funding, it would not be a luxury, it has fast become a necessity. 

Weekly Roundup - 04/25/08

The pollen is so thick, not even the Hot Air from Capitol Hill can blow it away.  My black car is perpetually yellow-coated.  Everywhere you look, blooming this and blooming that.  Even my contact lenses have a film on them!  It has been a long, hard week, beginning where I sliced off part of my index finger.... a auspicious beginning.  (Did you know that your finger print grows back?) 

But it is the end of the week now, so let's have another Weekly Roundup!

• Viewing YouTube Videos - By the way, if you receive Eye on FDA through a subscription service, you may not be able to view the YouTube insertions.  Therefore to see them, you'll have to come directly to the site www.eyeonfda.com. 
• Testimony on the Hill - Stephen F. Sundlof, D.V.M., PH.D., Director of the Center for Food Safety and Applied Nutrition provided testimony this week before the Subcommittee on Health Committee on Energy and Commerce about the food and cosmetic provisions of the Food and Drug Administration Globalization Act draft legislation where he essentially provided an overview of steps that the FDA has taken to ensure safety. 
• Really Bad Report Card on Post-Marketing Studies - This is about the last thing that industry needs right now, but the FDA has released the latest figures on how well industry has kept to post-marketing commitments and it isn't good news.  Bloomberg reports that agency "determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun..." - Look for more on that in the upcoming FDA reform package from Capitol Hill.
• Shire Vyvance Gets Approval for Adults - After a year where so many ADHD treatments have gotten approvable letters rather than approvals, the FDA has approved Shire's Vyvance, previously approved for use in children, for use in adults. 
• FDA Commissioner von Eschenbach Grilled on the Hill by Dingell - What's for lunch?  Grilled Commissioner. 

That's it folks. Have a good weekend!