FDA to Outsource Social Media Guidance!

After numerous delays attempting to issue guidance documents regarding pharmaceutical social media, the FDA’s DDMAC division has finally thrown in the towel and decided to outsource the task.

“Look, the pharma companies all use outsourced services, right?” stated N. T. Ropee, Divisional Director and Acting Adjunct Associate Abrogator of Responsive Guidance Production. “They have CROs (Contract Research Organizations), CSOs (Contract Sales Organizations) – so why shouldn’t we use a CGO (Contract Guidance Organization)?

“We figure they’ll get some smart people in a room and hammer this thing out in about 3 weeks. That’s the FDA goal: timeliness and efficiency!”

Pharmaceutical marketing executives were initially ecstatic, but enthusiasm rapidly cooled as Ropee began to explain the process of selecting a CGO for the project.

“First, we have to do a feasibility study to analyze the potential for a needs assessment, after which we’ll require a full market landscape analysis to narrow down the potential suppliers according to specifications not yet developed by the Directorate of the Division of Specification Development, which will then be followed by a pre-publication analysis of possible public commentary paths seeking input on potential information-gathering procedures, including a full re-analysis of the unpublished data from the incomplete guidance not published in the ’90s about the Internet, which will be followed by – don’t hold me to any time frames now – a review of all current, past, and future…”

It’s business as usual. Happy first day of April!

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“So, What’s Your Problem with Gram-Negative Bacteria??”

-by Bruce G.N. Bacterium, Esq.

It’s really unfair. All this bad press about gram-negative bacteria. Would you feel different if we were gram-positive? Well? Would you?

Here we are, just bumping along, doing a little harmless infecting of human hosts, and WHAM! – we’re suddenly the bad guy in all the newspapers.

So we occupy a little space in J&J’s Tylenol factory. Look, we’ve got to live somewhere, right? You going to consign us to some bacterial ghetto, like a BP oil rig, or maybe HoHoKus, NJ? But no – as soon as people find us near some kids’ medicine, everything shuts down and we get kicked out.

Again.

Hey, what would you rather have in there, bubonic plague? We’re just gram-negative, for crying out loud, trying to replicate like everyone else.  So what if we’re not positive like those other bacteria – everybody needs a little gram-negative, and whatever happened to diversity in the workplace? Who’s next – gram-neutral?

Go ahead, recall your medicines, and blame us. We’re always the bad guy. So we have lipoproteins attached to our polysaccharide backbones. Does that mean you can just dismiss us as unworthy pathogens? How many of your other bacteria can boast of sporting a cytoplasmic membrane?

But, I get it. We’re just lowly producers of cytokine reaction, and thus, we’ll always be misunderstood. But one day, you’ll wish you had some gram-negative to blame in your facility, instead of faulty SOPs or lax compliance records. Go ahead, bring on the Lysol. Just remember – we’ll be back!

Inspiration provided by this post from The Onion

(Image credit)

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FDA Hits Reset Button; Approves Everything

(Press Release embargoed until April 1) – ooops! Sorry….

In response to the endless backlog of work, and the constant carping of all of its constituents, FDA Chief Dr. “Big Maggie” Cheeseburg decided that the best way to clear things up was to do one massive, sweeping approval of everything on the docket and just start over.

“It’s like one of those Unification Church weddings.” said Ms Cheeseburg. “We told every staffer to just line up everything they have, and we stamped ‘Approved‘ on all of it. No muss, no fuss, no questions asked. Just call me Queen of Reset!

“The President appointed me with a charge to just ‘get it done.’ Looks like my job is done here. Can I be a Czar now?”

According to sources within the FDA, every drug that has been submitted for approval over the last 5 years is now fully approved for immediate marketing, no matter how tenuous the data. “‘Let the market decide’ is the new mantra here,” admitted one staffer who refused to be named. “Why should we go through all that paperwork hassle? If companies went to the trouble of submitting those piles of documentation for approval, then the drug must be OK. If not, we’ll all find out later.” Asked about potential patient deaths that might occur from unproven drugs, the source replied, “What? You’ve never heard of a mulligan?”

Drug manufacturers were ecstatic, especially over indications that any new drug approval applications submitted over the next 45 days would also be rubber-stamped as part of the Clear the Docket! holiday. Submissions included DarKissitor heart treatment from Hershey Pharmaceuticals, Cephalon’s ReVigil for nodding off during Cubs games, and GSK’s inhalable lung treatment Oxygenulate as add-on therapy with Advair Diskus.

Another inside source indicated to blogger/model Fabio that as of April 1st, all restrictions on social media marketing would be lifted. “The FDA will give no further guidance regarding on-line marketing because we just don’t care anymore. Say what you want. Talk among yourselves and leave us alone, for crying out loud. What are we, hallway monitors??”

It was reported that a Facebook Fan page for Wyeth immediately appeared, with a list of all their drugs by name, accompanied by a single-choice “Dislike” button. Comments were posted from on-line friends and fans such as Vladmir Putin, Sandy Cheeks, and the male model Fabio. It was later determined that the page was put up by an employee of another leading pharmaceutical manufacturer, who had forgotten that they had recently acquired Wyeth. The same rogue employee deneighed launching a Premarin the Mare Twitter account.

Belatedly, the FDA also voted unanimously to approve President Obama’s health overhaul, in exchange for another $100 billion of discretionary spending and weekend rides on Air Force One for staffers and their families.

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Fred Hassan buys division of GM; launches Hummer Pharmaceutical

Fred Hassan, pharma’s turnaround artist, has taken on his biggest challenge yet, buying up a money-losing division of General Motors to turn it into a profitable pharmaceutical company, suitable for re-sale.

Fresh off his gig turning Schering into a suitor for Merck, Hassan decided that he wanted to make his final professional venture a glorious one, something never attempted before. “I helped lead Wyeth, turned Pharmacia into Pfizer-bait, now did the old ‘clean house and flip’ with Schering. It’s time to take on a complete loser of an operation in a dying industry and turn it into a healthcare dynamo.”

Hummer Pharma’s first drug, a rather large pill code-named the H4, is to be submitted later this year for FDA approval. H4 is a targeted treatment for business executives suffering from Takeover Stress Disorder (TSD), a condition marked by anxiety over job retention and bonus retraction. Pent-up demand on Wall Street and in Detroit indicates that H4 may be a blockbuster, particularly in light of projections that the federal government will have taken over most industries by the time Phase III studies are complete.

Also in the pipeline is H5, the first armored pill for Legislative Incompetence Syndrome. Lobbyists have already begun approaching members of Congress for fast-track approval of the drug without review, since they seem to do a lot of that lately.

All executives at Hummer Pharma will drive – well, Hummers – that are currently languishing in inventory, until the manufacturing transition is complete. Details as to how a bunch of sheet metal factories would be churning out medications were not available as this story was filed, but hints were contained in a secret memo that UAW workers would be forcibly enrolled in Phase 1 safety and crash testing.

Rumors were already circulating as to who would take over Hummer Pharma once the transition to a healthcare company is complete. AIG Pharma, headed by Barney Frank, seems to be the leading early contender.

Oh…and Happy April 1st!

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New Treatment for PINS launches today!

Rumors have swirled around Behemoth Pharmaceuticals for months, but a press release has been scheduled for 10 am April 1st to announce the launch of PharmaBoost, a novel new treatment for Pharma Industry Negativity Syndrome (PINS).

“It’s been quite an ordeal getting this drug through FDA approval, and quite frankly, we were on pins and needles throughout,” said a relieved J.P. MacRost, President of Behemoth. “What pushed it over the edge was the incredible uptick in negative and inflammatory reporting about the industry over recent months – the agency finally could no longer deny that PINS is a pervasive and virulent disease.”

In a triple-blind, placebo-controlled and half-decaff clinical study which took place at 200 selected Starbucks outlets nationwide, 45% of those who formerly reported themselves as “mildly disgusted” or “thoroughly enraged” at the industry suddenly reported feeling “downright warm-and-fuzzy” after a shot of PharmaBoost was added to their morning fix by their trusted barista. In addition, 22% described their feelings as “mildly buzzed about pharma” when a venti was downed with a double shot of PharmaBoost. There were scattered reports of customers asking for “statin sprinkles” or “metformin muffins” with their coffee, but this was viewed as a transient side effect.

“These results are startlingly good,” declared Merry Angle, who once wrote a highly critical book about the industry (since retracted and removed from bookstore shelves after an infusion of PharmaBoost was slipped into her Earl Grey tea). “In fact, I’m putting out a series of articles defending the relative costs of sales and marketing expenditures, since this great healthcare system of ours was built on the principle of unbridled promotion and profit-making. Every time I see the price of a prescription nowadays, I think to myself, ‘Wow…what a bargain!’ Now, just thinking about the pharmaceutical industry gives me a high like no other drug I’ve tried!”

Peter Rost, industry gadfly and former blogger/critic, has renamed his blog “Give in to Authority” and now features puff interviews with CEOs of Big Pharma – the very ones he used to criticize in his whistleblower suits. In fact, Rost is now writing a new novel, tentatively titled “Swill yer Drug,” featuring a few surviving characters from his prior book (Killer Drug – now withdrawn from publication), who go about the countryside encouraging everyone to take their meds daily, in deference to the authority of their prescribing physician. “I don’t Question Authority anymore and neither should you!” declared an ebullient Rost, whose change of heart came after sipping a PharmaBoost-laced Red Bull during some boring legislation at which he was an expert witness. “In fact, this stuff makes me feel and look young again – maybe I’ll go back and apply for a Marketing job with one of these great companies again!”

Behemoth plans to launch a new social media site, “The Booster Club,” where pharmaboosters can share upbeat perspectives on the industry and talk appreciatively about their favorite high-level executives. A new ad campaign is also in the works, with huge displays of Big Pharma CEOs flashing up at Times Square, sequenced with the message “What else can $30 million buy you?” as former cheerleaders hand out PharmaBoost samples on the street, and Boosters stroll around with positive and upbeat signs.

PharmaBoost will be available in Regular size tablets for the general public, and Jumbo 12-packs for regulators, reporters, and Congressmen. An ultra-extreme infusion (the “Kennedy”) is currently under discussion with U.S. and European agencies.

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The End of Combo Drugs? Not!

So BiDil appears to have failed – putting together 2 cheap generics into one expensive prescription pill just didn’t prove to be a winner for NitroMed.

And, Merck/Schering-Plough just took a very public beating for Vytorin results that were none too keen.

And, for Pfizer, Caduet has been an ongoing disappointment – the 2-in-1 Lipitor/Norvasc combo is efficacious in lowering cholesterol, but not in raising sales.

So is that the end of the combo drug? Hardly! These companies simply did not go far enough. Announcing the next logical advance in combo drugs – Octomed!

Why settle for a mere 2 drugs per pill when you can have 8? New Octomed treats virtually everything that can go wrong with you (except for inflamed appendix and toe fungus – please see label) all in one handy pill.

Octomed is a combination statin (lowers cholesterol), acid reflux neutralizer (deals with that pesky indigestion), oxycodone (who doesn’t have a little pain now and then?), anti-depressant (if you’re this sick, you’ll need it), anti-leg-twitching stuff (just in case), blood thinner (hey – everybody’s doing it), hallucinogen, and placebo (for general hypochondria).

Doctors everywhere are flocking to Octomed, because it only takes one prescription to address the vast majority of real, imagined, or anticipated medical problems. In fact, many doctors are now just writing 8! on their Rx pad, simplifying the odious task of interpreting scribbles in the pharmacy.

The unique Octomed pill design is unparalleled in medical history. The multi-faceted pill is square, and its unique “color-cube” design allows the patient to visualize, if not world peace, at least the fact that he/she is getting a whole bunch of cool medicine in one whopping pill. For maximum psychological effect, physicians can even rotate the pill facets, thereby “optimizing” the treatment for each patient.

It is not recommended that patients “play” with their Octomed, as this may alter the delicate balance of substances carefully stratified in each pill.

In placebo-controlled studies, 15% of patients were actually able to swallow Octomed – most of the others required intubation and emergency surgery. Side effects included choking, bulging eyes, indigestion, and a vague sense of dread that something really bad was going down. All other symptoms and complaints previously described by the patient rapidly paled into insignificance, proving clinical success that was highly significant statistically.

Doctors and HMOs have embraced Octomed as an important way of preserving scarce healthcare resources, as those who are prescribed the treatment tend not to come back again. Ever.

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Copyright 2008 Impactiviti LLC

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Behemoth Pharmaceutical Hires Notre Dame Coach as CEO

In a surprise move announced today, Behemoth Pharmaceutical has hired Charlie Weis, former Notre Dame football coach, to be CEO.

“We needed some fresh leadership around here, and Charlie Weis, with his background in sports metaphors, seemed like the ideal choice,” stated Frank Gipper, current Chairman of the Board. “When he came and spoke to us about his vision for a winning healthcare company, we just knew that he could come on board and help us execute.”

According to Weis, “It’s a real battle out there, but the Behemoth team is clearly ready to play, and we’re just going to take it one molecule at a time. We’re not going to leave anything in the labs, but we’re going to lace it up and run the best discovery program we can. I’m pumped about our beta blockers, and also that product safety I’ve been hearing about. We might even get a few small-pharma transfers to beef up our offensive pipeline.

“On paper we’re as good as any of the other guys. Right now, it just comes down to blocking and tackling. Or dosing and titrating, or whatever it is we do. We’re going to put on a clinic with our clinical trials and stay focused, remembering that there is no “I” in TEAM.”

Behemoth staffers seemed cautiously excited about Weis, feeling the momentum shift as the home team lined up for the kickoff of the new leadership group. “It’s been a real pressure cooker here, but this was a gutsy hire, and it could mark the turning point for our company,” declared Sam Biotic, VP of Sales. “Some of our mature products are in a fourth-and-long situation, but we’re tossing our old game plan out the window, we’re going to fight it out in the trenches, and we intend to put some market share points up on the board.”

Others were not impressed. J.P. MacRost, Litigation Consultant and Pharmaceutical Marketing Expert Witness, said, “Hey…I’m supposed to be the big whistleblower around here. Where does this executive jock wannabe get off thinking he can call the shots? Has he ever testified before the Swedish Congress? Besides, he looks like he needs a serious jolt of Alli or something.”

In compensation for Weis, Notre Dame will receive a VP of Finance and a diuretic to be named later.

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The Pharma Side
Copyright 2007 Impactiviti LLC

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Lypitorin now recommended for Post-Trans RILV Bypass HAM-d New England Syndrome

In yet another clinical study to show the unique efficacy of Lypitorin, Phizer-Plow has announced the the drug is now approved for use with Post-Transplant Random Ischemic Left Ventricle Bypass Hypercholesterolemified Arterial Malfunction Disorder in New England Syndrome (abbr. Post-Trans NE).

While initially approved for simple elevated cholesterol problems, Lypitorin’s labeling has blossomed in recent years to cover virtually every cardiovascular disease known to man, culminating now in the holy grail, Post-Trans NE.

“We are absolutely delighted!” exulted Robert Jarvik, inventor of the artificial heart and first physician to accurately make up diagnose Post-Trans NE. “This terrible disease has afflicted at least 3 generations of one family in Vermont, and after several years of clinical trials, we have shown efficacy in addressing whatever symptom progression this syndrome apparently seems to be connected with. We think.”

Currently approved only for those living in New England with the syndrome, which presents with vague, poorly-defined symptoms of an indefinite etiology, it is believed that Phizer-Plow is aggressively pursuing approval for use in Missouri, the Florida Keys, and possibly northern Saskatchewan, where such symptoms have been reported for at least several months.

Because of the lengthy name and description of the syndrome, and due to the 47 other approved uses for the drug, Phizer-Plow now plans to re-package Lypitorin for sale in expanded pill bottles that can contain the 1,200-word label. The large, blue and white bong-like containers look suspiciously like dispensers for a product recently abandoned by the company, but a Phizer-Plow spokesperson quickly denied the connection, saying that it was only a coincidence that the expanded label happened to fit nicely onto containers shaped just like the 2 million unused Hexubera bongs currently in inventory.

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The Pharma Side
Copyright 2007 Impactiviti LLC

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Doctors now to be Required to Consult with Patients

In a stunning move, the AMA Board of Directors has confirmed that it has changed its guidelines, now requiring doctors to consult with their patients before subscribing medicines, reversing the long-standing doctor-patient relationship.

“It was simply a case of surrendering to the inevitable,” stated Rusty Scalpel, MD, current president of the organization. “With so much Direct-to-Consumer advertising, patients now know more than we do about current medications. I mean, who knew about ED until Viagra and its competitors started blanketing the airwaves? Some patient came to me describing a painful 4-hour effect, and I’m like, ‘Huh??'”

“I think it’s a great idea, ” said Frank Lee Clewles, a busy primary care physician in East Blizzard, ND. “I’ve got enough problems keeping up with insurance paperwork and government regulations. Who can stay current with all this medical stuff nowadays? Now, I can just take the time to sit with my patients and ask them about the latest treatments for urinary incontinence or pancreatitis. They’ll even point me to some great websites and we figure out a treatment plan on the spot based on their recommendations!”

From this point forward, when a patient presents with symptoms of a medical problem, doctors will be required to ask what medications the patient thinks will be most appropriate for that issue. A 20-minute loop of the most common DTC ads will play continuously in waiting rooms, to remind patients about treatments for toe fungus, weak streams, painful joints, and other real and imaginary ills. In addition, new doctor office wallpaper is being issued with the names of the 100 most common brand names, so that patients can tell their doctors exactly what they think they need.

Pharmaceutical companies were quick to respond, re-deploying their entire field sales forces as door-to-door salespeople.

(image credit)

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The Pharma Side
Copyright 2007 Impactiviti LLC

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Hexubera promotion goes terribly wrong

What seemed, at first, to be a terrific marketing idea ended in disaster this week, when, in the dead of night, a life-sized Hexubera “bong” was installed to replace the Leaning Tower of Pisa.

“We thought they were just putting up a banner or something,” howled Guido Marchesi, curator of the Pisa site, who thought that a promotional tie-in with another towering design fluke would bring some much-needed new revenue. “Instead, I come this morning and some massive bong has replaced my Tower. Although, I must say, my blood sugar level today seems better.”

According to N. Hale Sulin, Brand Manager for Hexubera, “Perhaps we were a bit over-the-top with this one, but hey, the dimensions were about the same for the Tower and for our delivery mechanism, and no-one can deny that the old relic needed some updating. Why not replace it with a modern example of remarkable design? Plus, we’ve got a few extra of these beasts in inventory – we’re checking with NASA now about first stage rocket needs.”

Local residents displayed a mixture of curiosity and outrage, some of them attempting to scale the massive bong in order to activate its insulin spray. After a few successes, a curious layer of snowy material covered the site, leading to a world-first insulin snowball-throwing contest.

“Wait ’til you see what the Lipitor brand manager has in mind for the LaBrea tar pits,” hinted Sulin. “We’ll be taking on that sticky cholesterol stuff once and for all…”

(credit to Pharma Giles for the idea on take-offs of the Exubera bong…)

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The Pharma Side
Copyright 2007 Impactiviti LLC

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