Pharma news highlights: January
Ed Silverman
pharmalot
The beginning of a new year is always a busy time as holidays end and schedules gear up for another year. But the pharma world commanded unusual attention recently due to a string of events - some expected and some not.
Novo Nordisk hire Paula Deen
Arguably, the most sensational was the decision by Novo Nordisk to hire Paula Deen, a self-proclaimed 'Queen of Southern Cuisine' and Food Network television host who is notorious for cooking unhealthy dishes. In itself, this seemed incongruous, given that the drugmaker markets treatments to people who should not be eating donuts filled with hamburgers, eggs and bacon for breakfast.
But Deen, as it turns out, suffers from Type 2 diabetes, she learned this three years ago and never disclosed anything - until she had the deal with Novo Nordisk.
Not surprisingly, this quickly prompted some to say she was an opportunist who was unsuitable to market diabetes meds to a diabetes crowd. And Novo Nordisk was criticized for making a poor choice and may find itself in the uncomfortable position of promoting unhealthy eating, which could undermine its credibility.
"...the most sensational was the decision by Novo Nordisk to hire Paula Deen..."
Then again, the drug maker clearly hopes the controversy will fizzle and, months from now, its market share will start to rise as diabetics associate one of their favorite chefs with its brand name meds. Already, you see, the gambit may have worked. Both Paula Deen and Novo Nordisk received enormous publicity from the episode, which raised their profile in ways that the usual efforts could not begin to match.
Risperdal Settlement
Credibility was also discussed when Johnson &, Johnson agreed to pay $158 million to settle a lawsuit brought by the Texas Attorney General over a campaign that was allegedly designed to promote the Risperdal antipsychotic.
The move came just one week into a trial in which a string of witnesses, including a former FDA associate general counsel, offered testimony that made the drugmaker look bad.
The details are complicated, but the main points are this - a 2004 whistleblower lawsuit filed by a former Pennsylvania state investigators charged that the drugmaker surreptitiously created and funded TMAP, or Texas Medication Algorithm Project, and relied on various state officials and academics to develop and sell this as a policy tool.
Two years later, the Texas AG joined the lawsuit, which offered a road map for the various ways that J&,J used to boost Risperdal market share. The drugmaker had already reached a tentative deal to pay as much as $1 billion to settle a federal probe into Risperdal marketing and resolve civil charges, and also agreed to a misdemeanor charge over the same marketing issues. And J&,J also lost verdicts in two other states where the damages were much larger than the Texas settlement.
"Given the chain of events and the evidence, J&,J made a bad bet by going to court in Texas."
Given the chain of events and the evidence, J&,J made a bad bet by going to court in Texas. Although the settlement was made for a comparably small sum, the health care giant risked its bruised reputation by allowing damaging evidence into the public record.
FDA legislation for COI for advisory panel members
In one of the more embarrassing reversals in recent memory, FDA commissioner Margaret Hamburg told a Congressional committee in early February that there was no need, after all, to introduce legislation to undue agency regulations governing conflict of interest rules for advisory panel members.
The confession came only months after Hamburg and one of her highest-ranking sidekicks, Janet Woodcock, who heads the FDA Center for Drug Evaluation &, Research, publicly and pointedly maintained that the agency was having a more difficult time finding qualified experts for its panels. Their statements occurred shortly before three lawmakers introduced a bill to reverse FDA regulations that bar experts with financial ties to drug or device makers from serving on committees without a waiver. Device makers, in particular, have pushed for a rollback. However, agency statistics actually show that the percentage of conflict of interest waivers granted for advisory committee members has remained below targets and the FDA vacancy rate for advisory committees has also remained low. Meanwhile, the FDA has been approving more drugs at a faster rate than in previous years. And over the past month, in fact, the agency approved four drugs in just three days, including a new type of treatment for some people with cystic fibrosis.
"The Daiichi Sankyo unit was caught fabricating bioequivalence and stability data..."
Ranbaxy fined
And in a closely watched development, the details of the consent decree between the FDA and Ranbaxy Laboratories were finally disclosed and the penalties should make every drug maker take notice. That's because Ranbaxy, which agreed to pay a $500 million fine, must relinquish any 180-day marketing exclusivity that it may have for three pending generic drug applications, as well as any 180-day marketing exclusivity that it may have for several additional generic drug applications.
There are other considerations, such as removing false data contained in past drug applications and hiring outside experts to review its operations.
In exchange, Ranbaxy was, of course, given the opportunity to sell a generic version of Lipitor. The Daiichi Sankyo unit was caught fabricating bioequivalence and stability data that was used to support AIDS drugs to be paid for by the President’s Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries, which angered and embarrassed US officials. And so the bargain, which could be very costly to Ranbaxy, underscores that US officials are trying to send a stern message to others that might try the same shenanigans.
The next ‘Pharma news highlights’ can be viewed here.
About the author:
Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for the past 16 years. In addition to editing Pharmalot, he is currently an editor-at-large for Med Ad News and R&,D Directions.
Previously, he was a bureau chief for The Pink Sheet, the venerable industry newsletter, and a contributor to its sister publication, In Vivo magazine. Before that, Silverman worked as a business writer for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, where he conceived and launched Pharmalot. During his 13-year tenure, he closely followed a variety of topics of concern to those who work for, and with, drug makers – drug development, mergers and acquisitions, regulatory oversight, safety and pricing controversies, and marketing issues.
Prior to joining The Star-Ledger, Silverman spent six years at New York Newsday and previously worked at Investor’s Business Daily, among other newspapers. He has a master’s degree in journalism from New York University and a bachelor’s degree in accounting from Binghamton University. Tethered to his laptop and Blackberry, Silverman lives in suburban New Jersey with his wife, three children, a sizeable labrador retriever and a sneaky beagle.
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