About Mark Senak

Mark Senak is an attorney with over twenty years of experience offering a blend of law, communications, public health and public relations.  He has designed communications campaigns and built coalition grassroots support efforts targeting public health and health policy issues at state, federal and global levels.  Senak is currently senior vice president at the international communications firm of Fleishman-Hillard.

Interview

ES: According to a 2006 Wall Street Journal/Harris Interactive poll, confidence in the FDA has reached a new low.  What are the major issues contributing to negative public opinion of the agency?

MS: There were a series of events that in concert have heavily tarnished the once gold standard of the agency.  First, there has been a lack of steady leadership for quite some time.  Since the tenure of Dr. David Kessler, no one has stayed in the role of confirmed commissioner for more than about 18 months.  Compound the lack of leadership with a series of highly public events, each by itself a crisis, and you have a downward spiral in the esteem of the agency, both outside and in. 

The agency got into hot water with policy makers on the Hill with the approval of RU-486 and their perceived slowness to react to the growing ephedra problem and the warnings associated with anti-depressants and children.  But then the flu vaccine fiasco whereby the British Medical Authorities closed down an American vaccine manufacturing facility in Liverpool – with the FDA being informed after the fact and resulting in a flu vaccine shortage that had members of the public waiting in long lines or being turned away altogether for a vaccine.  It was a highly visible gaffe.  Finally, there is of course, the post-COX-2 fallout – when a highly prescribed class of drugs approved by the FDA are found to carry cardiac risks and members of the FDA’s own ranks stated that the FDA was unable to adequately protect public health.  Most of this occurred with no one at the helm. 

ES: Critics of the FDA have suggested that it is beholden to the interests of the pharmaceutical industry.  To what extent is this true?

MS: I think that is a convenient peg on which to hang a lot of baggage, but I honestly don’t think it is true.  I believe that those who are employed at the FDA take their charge to protect public health very seriously.  I have worked with a number of companies across therapeutic categories in bringing new products before the FDA.  I have never seen an example where any company or any product was shooed through the process or not held to a high standard of scrutiny.  That said, I think there have been times where poor judgment has been exercised or where, in the leadership vacuum, there may be the appearance of some bias.  Some on the Hill have seized on this sentiment, pulling some outrageous publicity stunts in the process – but let’s face it – if you look up “beholden” in the dictionary, there is a picture of the U.S. Congress, not the FDA. The bar for drug approval is very high. 

People need to keep in mind that the United States has been the repository of innovation in drug therapeutics that has made a tremendous impact on the lives of millions of patients.  I think that the main issue for people is pricing.  The cost of drugs is an issue that is most evident to the general population, not risk.  Cost is something the FDA has no influence over, nor should it. If you consider the fact that drug innovation is becoming more and more complex, then you have to accept that the regulation of the industry is also becoming more complex.  Far more people have benefited from FDA’s oversight of the drug industry than have been harmed by it.  That is the risk/benefit equation – a message that the FDA should be pounding home, but has not.  The FDA instead has sat and absorbed one attack after another, and done little to defend itself or make its true role understood, allowing others to capitalize on mistakes – mistakes that frankly are inevitable. 

ES: Some have pointed to the FDA’s handling of Plan B as evidence that the agency is putting politics over science.  How valid is this critique?

MS: There is no such thing as a federal agency that works without political interference.  However, this Administration has taken that to new heights and clearly when it comes to Plan B, the science of the matter was put into place behind the politics of the situation.  Two FDA Advisory Committees overwhelmingly approved Plan B for an OTC conversion, despite the fact that one of the committees had ultra-conservative members.  The leadership of the FDA allowed itself to get hung up in matters of sex.  The FDA’s role is to judge the safety and efficacy of a drug – nothing else. 

What would have happened, for example, if the approval of protease inhibitors for HIV were held up because of a political concern that by providing access to treatment, the agency was encouraging homosexuality?  Millions of people would have died.  The agency, with Plan B, allowed itself to be manipulated into a political argument, not a scientific one.  That is something the agency cannot afford.  What happened with Plan B was outrageous and without precedent.  However, I think that this should be seen for what it is, a temporary anomaly, and not something that characterizes the primary goal of the agency, nor the commitment of the staff to matters of public health. 

ES: In a June 2006 post on your blog Eye on FDA, you said that the FDA is ignoring a basic tenet of crisis communications: “Do something.”  What is preventing the FDA from publicly acknowledging its problems and proactively addressing critics? 

MS: I think there are 3 principle reasons for the inactivity.  First, I do a lot of crisis counseling and one of the things I’ve noticed is that when an institution, like a person, is in crisis, one of the first things the do is deny that there is a crisis.  It is a natural comfort zone.  (The White House has done a great job of this.)  So I think that the psychology of it is one reason.  A second reason has been that there has been no one at the top who could step in and say… get me a crisis plan by yesterday…  And thirdly, government institutions generally lack the savvy of a corporate suite when it comes to communications.  Agencies have a mission whereas corporations have a brand and there is a great difference in the mentality behind the two.  But right now, the FDA would be far better off if they thought less like an agency and more like a corporation that has had its reputation sullied.  They need to protect their brand – instead they have yielded it. 

Crisis communications is a great field to work in, but it is also challenging.  First, there is the challenge of the crisis itself.  The best communications has to offer cannot do away with bad judgment calls.  The situation presents challenges that are exciting.  But there is also the fact that the client, whether an agency like the FDA or a corporation, tends to believe their own party line.  That is another challenge, because you are dealing with an entity that doesn’t understand the nature of the crisis, and in fact, does not believe a crisis exists.  I think the FDA did not understand the true nature of events that were re-casting its image in American society.  That, combined with a lack of leadership, were detrimental to the agency’s image. 

ES: What role do you think the FDA should play in regulating the pharmaceutical industry’s marketing activities?

MS: The agency has an entire division devoted to marketing -- the Division of Drug Marketing, Advertising, and Communications (DDMAC).  They are there to ensure fair balance in marketing and to ensure that companies do not make claims that are not based in data.  The agency is data driven.  Data that shows results – that is reviewed for showing those results, gets a stamp of approval.  I think that role is perfectly appropriate. 

ES: Do you think the FDA should ban direct to consumer (DTC) advertising?

MS: Actually I don’t for a number of reasons.  I don’t have evidence for this statement, but it is my gut feeling that DTC has contributed greatly to the health literacy of patients.  People who would not otherwise pay attention to their cholesterol levels are probably giving it a second thought when a well-known heart expert speaks to them about his feelings and knowledge regarding the importance of lowering levels.  That, in and of itself, is a tremendous achievement.  We cannot be so absorbed in risk, that we do not assess benefits associated with DTC.    

I know that there are problems associated with DTC ads  – about patients being educated with a slant, or about conditions that a few years ago had no name, but overall, I’d say that the benefits have outweighed any risks.  I don’t know anyone actually hurt by DTC.  But I do think many people have been helped. 

No government agency can act against all exercise of poor judgment in the market, either on the part of the seller or the buyer – whether it is a drug we are talking about or an automobile. But I do think DTC is very much about looking at things in balance and not merely yanking it because some don’t play the game well.  

Secondly, as a lawyer, I do feel that a ban on DTC infringes on the free speech of corporations, and though that free speech is at a lower threshold than individual speech, I still think it is important. In the end, I think if we applied a true risk/benefit assessment of DTC, the result would be that DTC provides more benefit than risk. 

ES: Some have said that because the FDA does not have the resources to adequately monitor the industry’s marketing activities, it should consider amending the Prescription Drug User Fee Act (PDUFA) so that it can allocate industry funds to marketing enforcement activities.  What do you think of this proposal?

MS: The FDA has a tremendous amount on its plate.  From the makeup applied by a woman to the drugs you ingest to the over-the-counter medications to considerations respecting the vitamin and supplement industry. 
It is a huge mandate. 

On the one hand, the money has to come from somewhere.  On the other hand, raising PDUFA fees to provide more resources for FDA scrutiny only fuels the debate that the industry has influence over the body it is meant to regulate.  That is a classic conundrum. 

I think that before we amend PDUFA to allow funding in this area, we need to get past that conundrum.  We need to be assured that, in fact, greater PDUFA fees do not equate with greater industry influence over the processes of regulation.  I am not aware of any definitive studies.  Given that this is a data driven agency, I’d like to see the data.  My feeling is that greater PDUFA fees do not tip the scales.  But the matter invites dialog. 

ES: What do you think will be the major communications challenges faced by the FDA in the next five years?

MS: There are so many, it is hard to pick just one.  I think that the role of the agency in risk management is going to grow, and that is a tremendous challenge not only from the regulatory point of view, but from that of communications.  The number of mandates on the agency is increasing, which puts a greater burden on the agency to communicate on a wider and deeper spectrum than ever before.  But if I had to choose one, I’d say the greatest challenge is in re-gaining their reputation.  The reputation has suffered a great deal.  Dr. von Eschenbach has signaled a readiness to address this by moving Plan B over the counter.  It will take more than that.  The agency needs to understand that it is still in a crisis situation and develop a sound communications plan that considers all of the public policy and public health challenges that lay before it.  Unless that happens, then the agency will continue to be victimized by political figures and circumstances beyond their control, allowing those forces to define the debate, rather than contributing to the debate and thereby shaping it from their own point of view. 

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