FDA

PHARMA – at Cooper Union – Shows How it Was Done

November 8, 2011 By tlaroche Leave a Comment

Philip Reynolds, VP, Associate Creative Director, Palio

If you find yourself in downtown Manhattan this November with a little time to kill, go to the Cooper Union, walk down the stairs, and check out an inspiring show called PHARMA, on view at the Herb Lubalin Study Center through December 3d.

The focus is masterworks of pharmaceutical graphic design and advertising from the 1940s to 1960s. If you think “masterworks” sounds too lofty to describe even the best of our hard-nosed industry, consider that mid-century giants Paul Rand, Lester Beall, Will Burtin, and Ivan Chermayeff all did pharma work.

The show lightly traces the whole history of pharmaceutical advertising, from its pre-FDA quack origins to the present day. You’ll see Ur-executions of now-familiar pharma concepts: the original chessboard, rowing crew, and suit of armor. Anyone hoping for an exegesis of contemporary pharma advertising will be disappointed, though. A bit of wall is hung with some satires (with predictably subversive lists of adverse events), but that’s it. I would have liked to have seen a serious discussion of work by the design stars of today, and how the best manage regulatory meddling that would have made Herb Lubalin throw away his calligraphy brush in despair.

But anything in the show that’s pre-WWII or post-60s is just there to provide a setting for the real jewels. The Mad Men ads, brochures, and packagings on display evoke a time when graphic masters were inspired by a confluence of optimistic forces: Visionary corporations headed by Swiss chemist-capitalists. Wonder drugs that promised to ease the strains of modern life. Faith in the power of great design to support and even add prestige to the image of a benevolent industry. And what an image they created — all in spite of (or is it because of?) the lack of Illustrator, InDesign, and Photoshop.

Palio is an advertising agency revolutionizing pharmaceutical and healthcare marketing to create experiences that will Never Be Forgotten.

Filed Under: Advertising, Creative, Industry Trends Tagged With: Cooper Union, FDA, graphic design, Paul Rand

Will the FDA Approve Tiger Blood?

April 20, 2011 By tlaroche Leave a Comment

From Sean O’Donnell, Group Copy Supervisor, Palio

New York (AP) — A sudden interest in the power of tiger blood has gripped Americans across the country, and has caught the Federal Drug Association (FDA) off guard. Charlie Sheen, the recently fired actor and quote sensation machine, has credited tiger blood for making him impervious to the “haters” and “trolls” and maintaining his superstar stature despite being fired from the mind-numbing comedy “Two and a Half Men.”

Currently, the FDA has stated that no companies have approached the Agency with studies linking success with drinking tiger blood. Dr. Ian Demeritt, chief wildlife expert at the FDA says, “If a company goes through the clinical studies and can make a case for the benefits of tiger blood consumption, we could conceivably give an indication for its use to maintain ‘rock star from Mars’ status and the long-term ability for attracting ‘godesses.’”

Despite the obstacles and costs facing a company from getting the FDA approval of tiger blood, Michael Osterhout thinks there is a huge opportunity in the market for such a product. As a leading marketer of tiger-related products, like Tiger Beat magazine and a line of acrylic nails called Tiger Talons, Mr. Osterhout feels the public needs more tiger. “After the Tiger Woods debacle, the tiger market really bottomed out,” he says. “Now there is an opportunity for a business to seize the aura of tiger blood and develop an energy-boosting beverage.”

Julie Priddle, a student at Manchester Community College and energy drink fan, couldn’t agree more. “Yeah, I’d totally try a tiger blood drink. Of course I wouldn’t want it to taste like my face was melting off,” she explained, “but I think it’d really give me a boost before heading off to English class.”

No other Charlie Sheen-related products have been brought to the attention of the FDA. At least for now. “I think we would have to draw the line at bottling Adonis DNA for public consumption,” explains Dr. Demeritt, “That patent is held exclusively by Mr. Sheen.”

*If you believe a word of this, a box set from season 3 of “Two and a Half Men” is being shipped to you shortly.

Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.

Filed Under: Advertising, Creative, Industry Trends, Lifestyles Tagged With: Charlie Sheen, FDA, Tiger Blood

A History Lesson: Who Will Educate Healthcare Providers About Drugs?

April 7, 2011 By lgoodale Leave a Comment

From Steve Dubansky, MD, SVP, Medical Director, Palio

Below you’ll find a thought-provoking and informative editorial from the March 30 issue of the New England Journal of Medicine. The author is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics. He asks, but only begins to answer, the fundamental question above. Below are 2 quotes from the piece that should intrigue you enough to want to read on. At the editorial’s conclusion, you’ll find a hyperlink to a 1-minute-and-20-second excerpt from Dr. Avorn’s lecture on this topic at Harvard Business School.

“The evidence base available to clinicians to guide their therapeutic choices is still heavily shaped by industry-sponsored studies that often compare new products with placebo, measure their worth in terms of surrogate markers such as laboratory test results, or both.”

“They [package inserts] live on as tangled obfuscations filled with minimally usable data and liability-averting warnings.”

Perspective

Teaching Clinicians about Drugs — 50 Years Later, Whose Job Is It?

NEJM | March 30, 2011 | Topics: Drugs, Devices, and the FDA

Jerry Avorn, M.D.

This year marks the 50th anniversary of the Kefauver hearings, the pivotal 1961 Senate debate that transformed prescription drug approval and use. When Senator Estes Kefauver (D-TN) introduced legislation to regulate the drug industry, the Food and Drug Administration (FDA) still did not have legal authority to require pharmaceutical companies to demonstrate that their products actually worked. What physicians knew about prescription drugs was shaped predominantly by the claims their manufacturers made about them, and the evidence base underlying such claims was often rudimentary, or worse.

Closely related to the thinness of the science was the question of how information about a drug’s benefits and risks should be evaluated and communicated to physicians — and by whom. Then as now, pharmaceutical companies mounted aggressive promotional campaigns for their products. An unsigned 1961 Journal editorial titled “Ethical Drugs — Who Shall Educate the Physician?” noted with concern that “manufacturers spend about four times as much on the promotion of drugs as the total cost of running all the medical schools.” As a result, the editorial continued, “the majority of physicians get their first and often their only information about newly available drugs from these sources, which at best may be strongly prejudiced and at their worst are unreliable and misleading.”¹ No mechanism existed for robust, arm’s-length governmental determination of a drug’s efficacy and for the dissemination of such data — a solution that many clinicians did not favor in any case. As a result, practitioners were often left with little disinterested guidance about the usefulness or safety of new medications in comparison with their alternatives.

Among other things, the Kefauver legislation sought to have the federal government provide a more even-handed, public source of drug education for physicians: a leaflet that would accompany every prescription medication describing “all the information about the activity, uses, and untoward effects of the drug”; a compendium of such information for all products “in convenient and readable form” to be distributed widely; and an annual list of medications with high potential for serious side effects.

The American Medical Association (AMA), skeptical about any public-sector role in health care, argued that this was not a proper activity for government and that such communication should be the responsibility of the profession itself, along with industry. The AMA had been attempting to fill this function through its Council on Drugs, a group of researchers and clinicians that evaluated new medications and issued a “Seal of Acceptance” to those meeting its standards. Only drugs thus accepted could be advertised in the AMA’s journals.² However, NEJM‘s editorialist lamented in 1961 that the AMA had largely dismantled these programs, a decision that led to “encouraging the introduction of relatively inferior drugs . . . [and] the deterioration in the quality of advertising and promoting such drugs. These changes have done little to help but may have done much to confuse the physician in his efforts to practice good medicine.” The Journal noted that this failure undercut the AMA position that a governmental program was not needed.

The pharmaceutical industry and the AMA attacked Kefauver’s bill, and the idea that the government should play a central role in evaluating medications for efficacy and disseminating information about them seemed headed to legislative defeat. Then came the thalidomide disaster. That drug was being heavily promoted in Europe as a sedative and antinauseant, particularly for use during pregnancy, but a more cautious FDA approach had spared Americans the epidemic of fetal limb-reduction defects that plagued countries with more permissive drug regulatory systems. Empowered by this crisis, the Kefauver hearings resulted in a new law that gave the FDA the authority to require evidence of efficacy and safety before a drug could be marketed.³ The debates about disseminating drug information eventually led to the now-familiar “package inserts” that fit the law’s requirement for completeness, even if they have still not lived up to its larger goals of usability and readability.

Half a century later, the editorial’s question, “Who shall educate the physician?” is still hotly contested. Opposition to a role for government did not carry the day then but has dominated debate ever since; the letter of Kefauver’s legislation about drug information has been followed in one narrow sense, though its spirit has not fared as well. The evidence base available to clinicians to guide their therapeutic choices is still heavily shaped by industry-sponsored studies that often compare new products with placebo, measure their worth in terms of surrogate markers such as laboratory test results, or both.

The recent comparative effectiveness movement holds great promise for improving this evidence base, if it survives politically. Package inserts have been legally mandated, but until recently their content was determined primarily by the manufacturer, not the FDA. They live on as tangled obfuscations filled with minimally usable data and liability-averting warnings. Proposals for improving them are floated periodically, and 2007 legislation may give the agency more power to address this problem. But for the most part, the 1961 vision of an unbiased, user-friendly, practical summary of benefits and risks produced by the government for each prescription drug has not come to pass.

On the education front, recent reforms have only partially addressed concerns about the undue influence of drug companies on what physicians know (or think we know) about medications, mediated through aggressive promotion, less visible and more indirect public relations campaigns, and a manufacturer-dominated continuing medical education industry. The 1961 editorial’s reference to “ethical drugs” — an old term for prescription medications — seems oddly archaic in a time of scandals about deceptive marketing practices and heavily advertised, costly medications that turn out to have major unreported risks.

One positive response to the editorial’s question has been the outreach activities that have evolved to disseminate noncommercial drug information to clinicians. The Agency for Healthcare Research and Quality (AHRQ) has long tried to provide a public-sector source of evidence-based information on drugs and other interventions. It initially did its job so effectively that in the mid-1990s it was nearly defunded after pressure was exerted by advocates for treatments that were more lucrative than effective.⁴ A chastened AHRQ has remained engaged in this area but is reluctant to issue therapeutic guidelines that could again threaten its existence.

As the United States turns away from 1960s-era belief about government’s role in protecting the public health, and as concern grows about industry’s influence on federal policy positions, the answer to who shall educate the physician is increasingly unlikely to be “Uncle Sam.” Instead, an emerging answer may be public–nonprofit collaborations for which the government provides funding but profession-based nongovernmental entities with no ties to industry generate the scientific content. One illustration is the growth of support for “academic detailing” — educational outreach programs in which independent researchers and clinicians systematically review data for a given therapeutic area and develop noncommercial, evidence-based recommendations about treatment choices. Pharmacists, nurses, and physicians are then sent to visit practitioners in their offices to present these findings, drawing on the successful marketing strategies of industry but without its sales-oriented spin.⁵ Several states, insurers, and federal programs currently fund academic detailing programs based on content developed by nonprofit organizations free of industry ties. As concerns grow about the safety, complexity, and affordability of our expanding pharmacopoeia, demand for these programs increases.

Fifty years after the Journal grappled with these issues, they are even more relevant, and the need to provide reliable drug information to physicians is even more pressing. Enlightened by our tumultuous experience with medications and drug communications over the past half-century, we are still working on a sustainable answer to this question that lies at the heart of medical practice.

Source Information

From Harvard Medical School and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital — both in Boston.

References

1. Ethical drugs — who shall educate the physician? N Engl J Med 1961;265:910-912

2. Greene JA, Podolsky SH. Keeping modern in medicine: pharmaceutical promotion and physician education in postwar America. Bull Hist Med 2009;83:331-377

3. Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton, NJ: Princeton University Press, 2010.

4. Gray BH, Gusmano MK, Collins SR. AHCPR and the changing politics of health services research. Health Aff (Millwood)2003;W3-283-W3-307

5. Avorn J. Devising an antidote. In: Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York: Alfred A. Knopf, 2005:313-38.

http://www.youtube.com/watch?v=uONt4kumkIk

Filed Under: Industry Trends, Medical Strategy Tagged With: AHRQ, FDA, NEJM, package inserts

Naming Names: Juliette Capulet Was Right

March 9, 2011 By jfisher Leave a Comment

From Steve Dubansky, MD, SVP, Medical Director, Palio

In 1999 the Institute of Medicine published a report entitled To Error is Human: Building a Safer Health System. The report cited two major studies stating that from 44,000 to 98,000 patients die in hospitals each year as a result of preventable medicine-related errors. Moving with its usual alacrity, the government ordered the FDA to fix the problem in 2007. Congress, realizing the urgency, passed a law asking the FDA to offer a solution by September 30, 2010.

Yet, as noted by Stephen Barlas in P&T in October 2010, “…the FDA to date has no guidance, much less regulations, on the naming of drugs. Typically, when a drug company applies for approval of a new product, the FDA uses techniques such as human factors development and failure modes and effects analysis to determine whether the name is acceptable.”

Presently the agency and their agencies assure themselves that new drugs avoid drug names that have orthographic or phonologic similarities to drugs already on the market. Physicians have notoriously bad handwriting, and I assume that either we mumble more than the average person, or pharmacists on the other end of the line have a higher than normal prevalence of hearing loss.

The FDA reviews about 400 drug names a year and rejects about one third of them. The institute for Safe Medical Practices in conjunction with the Joint Commission publishes a LONG list of look-alikes or sound-alikes. Examples listed (http://www.ismp.org/) include:

Aciphex	Aricept
Actonel	Actos
Adderall	Inderal
ALPRAZolam	LORazepam
Allegra	Viagra
AVINza	Evista
Asacol	Os-Cal
Amicar	Omicor
Advair	Advicor
Avandia	Coumadin (really?)

In addition to look-alikes and sound-alikes, the agency now proscribes using names that imply efficacy (Paingona, Snotclyr) and dosing interval (Onlyonceawik). They will reject drug names that are misleading, including names that suggest the name of one or more but not all of the drug’s ingredients, or names that imply the drug is superior to a competitor. It wasn’t always this way: Lopressor (lower blood pressure), Coreg (help regulate heart rhythm) come to mind.

In Act II, Scene II of Romeo and Juliet, Juliette Capulet says to Romeo Montague, “Deny thy father and refuse thy name.” She suggests it because their love is more powerful than the feuding between the Montagues and Capulets. She follows with, “What’s in a name? That which we call a rose by any other name would smell as sweet.” She’s simply saying she loves Romeo and the Montague name is of little concern to her. For Juliette, a name is an artificial and meaningless convention, not nearly as important as the individual who bears it. For too many pharmaceutical companies, the names of their products are now becoming similar meaningless appellations.

There are appropriate restrictions on naming, but it seems as if the FDA has totally emasculated efforts to allow creative and meaningful product names. Some brands do seem aptly named (Femara has an obviously womanly tone) and Sonata (I can hardly say it without dozing off). But while many names are aptly named, many others are awfully named. You know what brands I’m speaking about. Their names seem to have been made up by a computer or a random drawing from a scrabble box, often nothing more than an incomprehensible and/or unpronounceable olio of letters.

Many might say that their names are integrally connected to the success of this or that blockbuster brand. I say “Phooey.” Brands are blockbusters most often because they are novel, first-in-class products in disease states with a real need and a high prevalence, or they have real (or perceived) advantages over their competitors. But a name that actually tells you something about the drug certainly can’t hurt sales. Lipitor, a #1 selling statin from start to patent expiration this year, wasn’t first to market, but it had great data and a name that surely implied “lipid” to any physician.

Filed Under: Medical Strategy Tagged With: FDA, Institute of Medicine, Juliette Capulet, Stephen Barlas

Social Media in Pharmaceutical Marketing

February 16, 2011 By jfisher Leave a Comment

From Michael Villanella, Copywriting Intern, Palio

While the FDA and DDMAC are still on the drawing board setting regulations for social media healthcare marketing, we are left shrugging our shoulders. What can we do?

Social media regulations have been delayed by the FDA to a Q1 2011 draft date, so unfortunately all we can do is sit back and wait, right? Well, not exactly.

Many pharmaceutical companies are making the push now. Instead of giving in to fear, companies like Johnson & Johnson are taking small steps to embrace the social media phenomenon. Thus finding ways it can be done.

Just about a year ago, J&J started a blog on their website called “JNJ BTW.” The blog hits on a very personal level with staff anecdotes and follower feedback. Although they aren’t talking about any products or FDA regulated issues, they are successful in promoting their brand and making “friends.”

In this intimate community, Johnson & Johnson makes each of their 5,000+ followers feel like an individual instead of a number — something that is often neglected in healthcare.

Of course the fear of adverse event reports is always present in a social media venue, but J&J is looking for new ways to combat this. In a separate community called Children With Diabetes, J&J actively combs over and monitors the bulletins for inaccurate reports. This seems a little taboo but, nonetheless, necessary to penetrate the social media world.

As this develops further, there are a few events to keep an eye out for. The Social Media and Community 2.0 Strategies event will be held on April 4^th-6^th in Boston. This event focuses solely on brand promotion strategies by means of social media. There was also just recently the ePharma Summit on February 7-9 in New York City. The ePharma Summit included FDA and DDMAC updates on the regulations.

With these two events and a Q1 draft date (fingers crossed) just around the corner, 2011 is shaping up to be a pivotal year for pharmaceutical marketing. Until then, tread cautiously with your social media endeavors. Just remember that practical solutions can be made today!

Filed Under: Creative Tagged With: DDMAC, ePharma Summit, FDA, social media

Time For a New Label?

November 16, 2010 By jfisher Leave a Comment

From Langdon Jenkins, Associate Creative Director, Palio

Buried in the September 24^th New York Times article entitled “F.D.A. to Severely Restrict Diabetes Drug Avandia” I found this little nugget:

“In explaining why the F.D.A. decided against only adding warnings to Avandia’s label, Dr. Woodcock, director of the F.D.A.’s drug center said, ‘We know that labels are often not read.’”

Hmm.

Well if labels aren’t often read, how about the Prescribing Information? How about the Important Safety Information?

As a person who spends a good part of his day making sure that there is enough safety information on a page to balance any claims that are being made, and that the safety information is not hidden, disguised, or less prominent than any other aspect of the page, I already knew that.

The question I have is, which brand will be the first to try something new and better? Which brand will have the incentive to put something different in front of the F.D.A. for review? Which brand will make the rules instead of being constantly obsessed about breaking them?

Yeah, yeah, yeah, I know I’m a dreamer. But somebody has to be first.

I’m ready – are you and your brand?

Filed Under: Creative, Industry Trends Tagged With: FDA, Prescribing Information

A New Fast-Track Approval Process for Pharma?

August 6, 2010 By jfisher Leave a Comment

From Mark McCoy, SVP, Brand Planning Director, Palio

Recent developments have opened up a better, faster, cheaper route to market for new medicines. Marketers should seriously consider the medical marijuana commercialization path as an alternative to the tradition route to market via the FDA approval process.

Medical Marijuana Indications

Consider the status of medical marijuana in the state of New Mexico today. Marijuana is approved for use in 15 disease indications in that state.

Amyotrophic Lateral Sclerosis	Hospice patients
Cancer	Inflammatory autoimmune-mediated arthritis
Crohn’s disease	Intractable nausea/vomiting
Damage to the nervous tissue of the spinal cord with intractable spasticity	Multiple sclerosis
Epilepsy	Painful peripheral neuropathy
Glaucoma	Post-traumatic stress disorder
Hepatitis C infection currently receiving antiviral treatment	Severe anorexia/cachexia
HIV/AIDS

8-Member Board Provides Approvals

The approval process for gaining a new indication for medical marijuana is much less rigorous than the process required by the FDA. For example, according to the New Mexico Independent, Representative Sal Pace said, “An eight-member board of physicians in New Mexico just verified that medical marijuana does assist fight (sic) the symptoms of PTSD.” The pharma industry could save billions in R&D costs every year, by gaining approval of the 8 New Mexico physicians instead of the FDA.

Trend Is Sweeping the Nation

New Mexico is not alone. There are 14 states that currently allow the use of medical marijuana: Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington. Many other states are considering making marijuana legal.

Precedent for Bypassing FDA

For the pharma industry, the legalization and commercial sale of medical marijuana represents a tremendous precedent. The states have allowed a drug to be sold and promoted for the treatment of extremely common diseases without the benefit of any FDA approval or oversight.

New Competitive Advantage?

A pharma company wishing to sell a new drug for glaucoma, for example, could follow the medical marijuana route to market. This new glaucoma drug could gain breath-taking advantages over its competition. The glaucoma drug maker could conduct minimal or no clinical trials, realizing vast savings in time and money. The company could forgo Good Manufacturing Processes (GMPs) and the need for Prescribing Information (PI). If challenged, the pharma company could argue that they are merely following the same process used by a previous drug that is also approved and sold for the treatment of glaucoma. It could not be argued that marijuana is an herb or a botanical and not a drug, since marijuana is classified as a class 1 narcotic by the federal government.

The Spark For A Pharma Industry Boom?

It would be fascinating to see a net present value analysis for a new a drug comparing the profitability of the commercial asset if it were developed through the traditional FDA route or the wide open medical marijuana route. If this new route to market were exploited by the industry, patients, physicians and investors would all benefit handsomely.

Filed Under: Brand Planning, Medical Strategy Tagged With: FDA, glaucoma, medical marijuana

Sound a little fishy?

July 6, 2010 By jfisher Leave a Comment

From Frank Edwards, Group Art Supervisor, Palio

Recently, late night cable has been running, in heavy rotation, a DTC television campaign for a product called Lovaza. This is the new fish oil supplement that is being marketed and sold as a prescription medication.

The spot shows several smart-looking research scientists (wearing glasses) on the ocean floor, walking around their futuristic sea lab talking about the benefits of fish oil. We never see any marine life in this spot. I bet they were cut during the review process, but they are noticeably absent in this lifeless ocean. The visuals are interesting because they show a beautiful clear blue ocean which is in stark contrast to the images we see every day coming from deep below the Gulf of Mexico. We may all have to look for such a supplement as the world’s oceans become harder to fish.

Because many people are already aware of the health benefits of fish oil supplements, the clear message of this spot is that this product is all natural. And, therefore, like organic produce at the farmers market, it’s very good for you. But their Web site goes one step further. They state that although this medication is made from an all-natural ingredient it is actually better than Mother Nature’s because the product undergoes a purification process to take all that nasty pollution, like mercury and environmental toxins, out of the fish oil. Plus, its manufacture is overseen by the FDA, which ensures a quality standard superior to dietary supplements.

Its concentrated dosage allows you to take four prescription pills a day as opposed to 18 pills of a dietary supplement. The main drawback seems to be cost. The price of a supplement is $10 a month as opposed to $160 a month for the prescription. Here’s a little more info on it.

It is interesting to note the shift to this non-traditional strategy. Instead of extending a prescription drug’s life by going over-the-counter, they’ve decided to take an OTC dietary supplement and offer it in a “prescription strength” formulation. I am sure a lot of people are watching to see if this strategy pays off.

Filed Under: Creative Tagged With: DTC, FDA, fish oil, Lovaza

Paying the Piper

June 8, 2010 By jfisher Leave a Comment

From Peter Hopper, VP, Account Services, Palio

I’ve been teaching my 16-year-old son how to drive. Being aware of, and respecting, law enforcement is part of the syllabus.

We’ve noticed that there was a notably higher presence of local and state police on “speed-limit enforcement details.” And it wasn’t just at the end of the month, looking to fulfill quotas. Then I heard on the radio – maybe it was Click & Clack on Car Talk – that it was not our imagination. Indeed, across the country, it appears that there are more and more officers on the road. More patrols result in more tickets, which generates more revenue for local municipalities. Let’s do the math: 100 more tickets a day at an average of $200 per ticket equals $20,000. That can add up to real money. With strained budgets, this revenue flow helps offset deficit budgets.

Hmmm.

A colleague of mine, in a post-presentation discussion on the FDA’s new “Bad Ad” program, made the point that when the FDA levies penalties on pharmaceutical companies for non-compliance, which can easily be in the hundreds of millions of dollars depending upon the severity of the violation(s), that money goes into the US Department of Health and Human Services’ revenue stream when the action is taken by the Agency and not the Department of Justice. Just as an example, recently, biotech drugmaker Genzyme agreed to pay a $175 million penalty for long-standing manufacturing problems.

Now, the “Bad Ad” program has many attributes including great PR for the FDA to demonstrate its increased efforts to police the industry, and the casting of a wider net by enlisting the professional public to monitor and report. Perhaps we can add to the list balancing the budget.

For a government keen to regulate, but challenged with funding priorities, could it be the perfect way to pay the piper?

Filed Under: Industry Trends Tagged With: Bad Ad, FDA, Genzyme