The behind-the-scenes battle continues to rage between the FDA and a determined group of patients and investors who have agitated for nearly three years for the agency to approve the Provenge prostate cancer vaccine. Known as Care To Live, they are appealing a federal court decision denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel.

The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Freedom of Information Act, some of which the group maintains were deleted, destroyed (see here) or simply not produced in accordance with the law.

In a bid to avoid oral arguments, the FDA has filed a brief arguing that Care To Live and its attorney have made allegations about FDA conduct without factual support; charged Pazdur with lying about his document production; continue to promote a ‘conspiracy theory’ and engages in ‘baseless speculation;’ and the group has made ‘baseless attacks.’ Here is the FDA filing.

Of course, their effort may be overtaken by events, because Dendreon, which makes Provenge, has a May 1 PDUFA date. The real issue, though, is how the FDA handles alleged conflicts. As noted previously, the Provenge episode was a pox on former FDA commish Andy von Eschenbach, whose staff turned the proverbial tin ear to this drama. So far, it remains to be seen whether Margaret Hamburg, the new commish, will is either failing to be more responsive such concerns remains to be seen.

The research collaboration between Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency, according to FDA legal counsel Ralph Tyler, The Baltimore Sun writes.

But Woodcock voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals, which raised the allegations last April, the paper reminds us. Both companies are developing a generic version of low molecular weight heparin, which is currently sold by Sanofi-Aventis as Lovenox.

“We’ve determined that there’s no conflict here,” Tyler tells the paper, adding that as an “act of good grace” Woodcock stepped aside from any involvement in both applications last August. He adds an investigation by the Department of Health and Human Services Inspection General has been dropped.

But an Amphastar attorney couldn’t believe it, noting the FDA sent a letter last September saying there was no conflict. “Why did she step aside right before they sent us a letter telling us that she has no conflict?” Jason Shandell tells the paper. “And why didn’t they tell us that she stepped aside?” And he complains that contacting reporters before notifying his company, “flies square in the face of transparency” advocated by the Obama Administration.

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Prescription drug spending is expected to have grown 5.2 percent in 2009, a 2 percent rise from 2008, to $246.3 billion, and growth in the use of prescription drugs per person was driven by an increase in the use of antivirals related to the H1N1 virus, according to a report in Health Affairs.

Another factor was higher price growth for brand-name drugs, as the Consumer Price Index for prescription drugs has increased from 2.5 percent in 2008 to a projected 3.4 percent rate in 2009. By 2011, drug spending growth is expected to accelerate to 5.6 percent. In 2012 and 2013, there will be a pause as big-selling meds lose patent protection and lower-cost generics become available. As a result, price growth is expected to fall from 3 percent in 2011 to 1.9 percent in 2012. And growth in spending should reach 4.7 percent in 2012 and 5.4 percent in 2013.

Prescription drug spending growth is anticipated to accelerate through 2019, reaching 7.7 percent that year. Increases in drug prices are expected to account for about half of this growth. Also, expected increases in the number of new drug approvals, as well as an increase in the share of expensive specialty drugs, are projected to result in accelerating growth.

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?

And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Genzyme hired Lilly’s former head of manufacturing, Scott Canute, to run manufacturing and operations. He will be in charge of pulling rabbits out of hats, given Genzyme’s embarassing problems at a plant that was briefly shut down last year after a virus was detected. There were also bits of trash found in some drugs.

Chimerix hired Gwendolyn Painter as chief medical officer;
YM BioSciences added Robert Watson to its board;
Alnara Pharma added Ashley Dombkowski to its board;
Hemispherx Biopharma named Chris Cavalli as director of quality control;
Hemispherx Biopharma named Robert Fidanza as director of quality assurance;
Nektar Therapeutics added Scott Greer to its board;
MedImmune named Peter Greenleaf as president;
Fibrocell Science hired David Pernock as ceo;
BioClinica hired Robert Sammis as vp finance for its eClinical division;
Weinberg Group hired Carol Bognar as sr director for Good Clinical Practice svces;
DLA Piper added former Pfizer asst general counsel Carlton Wessel as partner;
GlaxoSmithKline hired Philippe Fauchet to head its Japanese subsidiary;
Lupin added Richard Zahn to its board;
Human Genome Sciences hired Scott Habig as vp of sales;
PharmaNet named Steve Leventer as vp clinical research neuroscience;
Diteba Research Labs named Sam Ricchezza as sr vp of business development;
Norwich Pharma named John Bender and James Kwon as directors of business development.

Ladder shot thx to Robert CB on Flickr Creative Commons

And so, another week will soon draw to a close. Our plans for the weekend? Snowballs fights with the short people may be in order, if the weather forecasts are accurate. What about you? Perhaps it will be time to catch up on some reading or take in a flick. Whatever you fancy, we hope you have a good time. Meanwhile, here are a few things to help you through the day. Enjoy, everyone…

AstraZeneca Still Waiting For Upside To MedImmune Deal (Bizjournals)

Glaxo To Close R&D Site In Italy (Bloomberg News)

Vertex Loss Grows With Costs (Reuters)

FDA Wants More Info On Protalix Gaucher Drug (PharmaTimes)

snow pic courtesy of katmere flickr creative commons

And he hoped to use the info to set up a pharmaceutical company in India. Shalin Jhaveri, 29, worked as a technical operations associated since November 2007, but was fired the Bristol-Myers’ Syracuse, NY, facility this week, Reuters reports.

“Jhaveri stole numerous trade secrets as part of a plan to establish a pharmaceutical firm in his native India which would compete with Bristol-Myers Squibb in various markets around the world,” the Justice Department said in a statement, according to Reuters. He was arrested and ordered held without bail ahead of a detention hearing on Monday. He could face up to 10 years in prison and a $250,000 fine.

He was accused of taking more than 1,300 documents from the company that he spent hours over the course of several days downloading to his laptop and portable hard drives, according to an FBI affidavit filed in a New York federal court, Reuters continues.

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In response to recent merger activity, the agency is seeking a budget of $314 million, which amounts to a 22 percent increase, in fiscal year 2011. This would pay for 1,207 full-time staff members, up from 40 this year, and would include 17 people to “maintain competition.”

Of those, nine would be tasked with the “increased workload” caused by increasingly complex mergers, notably in pharma, health care, energy and technology. And four of the nine would oversee pharma and tech deals. “Preventing anticompetitive pharmaceutical mergers will continue to be an important priority for the FTC and a vital way to protect consumers from rising drug prices,” the agency wrote in its budget summary.

As The Pink Sheet notes, the White House has already shown interest in scrutinizing pharma with some high-level appointments. In April, Public Citizen’s David Vladeck was tapped to head the FTC’s Bureau of Consumer Protection. And in November, Julie Brill, who was an assistant attorney general for consumer protection and antitrust in Vermont, where she spearheaded efforts to publicize pharma payments to docs, was nominated as an FTC commish.

Amid all the cutbacks drugmakers are undertaking, Bristol-Myers Squibb is now freezing salaries this year across the board and also eliminating the future deferral of vacation time, according to a communication that ceo Jim Cornelius sent to employees yesterday. Bonuses, however, won’t be hit, which would seem to favor execs (look here). A spokesman confirmed the move but declined further comment.

The belt tightening, which garnered some choice comments on CafePharma, comes as most every big drugmaker is shedding employees - GlaxoSmithKline, Pfizer, AstraZeneca, Merck and Lilly have all taken such steps. Like others, Bristol is bracing for the 2012 patent expiration of Plavix, the $8 billion blood thinner it co-markets with Sanofi. The the WSJ health blog also reported this item.

Top of the morning, everyone. How are you today? Feeling sunny and breezy, perhaps? Hopefully, the answer is yes. And why not? Another day is at hand and, despite the meetings and deadlines, there is always the sense of accomplishment that lies ahead. So as you plan your next moves, here are a few items to help you get started. Cheers…

Glaxo Plans More Cuts As Flu Windfall Dissipates (Reuters)

AstraZeneca Faces 26,000 Seroquel Lawsuits (Bloomberg News)

Poniard Cuts Workforce And Names New CEO (Reuters)

Former Novartis ceo Dan Vasella’s 2009 bonus will be close to three times the amount he would be due based on relative earnings growth among large cap peers, according to a report compiled by UK proxy voting agency Manifest and Swiss consultancy Obermatt, Reuters writes.

The estimated payout will total about $5.96 million. And that would be around $3.8 millionabove the maximum level calculated by Obermatt, which bases its bonus recommendation on the number of peers a company outperforms - the more peers are beaten, the higher the bonus. Novartis couldn’t confirm the estimated bonus level for 2009. “Dr. Vasella’s base as well as total compensation is in line with that of CEOs from other large healthcare companies,” a Novartis spokeswoman tells Reuters.

Vasella stepped down as ceo this week after 14 years, but remains chairman, and his pay package of nearly $19 million has come under fire from investors, Reuters notes. “The company needs to articulate to investors why they think it’s appropriate to pay such a level of bonus when the economic performance of the company would not appear to justify it,” Manifest ceo Sarah Wilson tells Reuters. “It is shareholders’ money after all and it is reasonable that they get some kind of explanation.”

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