“The administration strongly supports passage of S. 3187, the Food and Drug Administration Safety and Innovation Act, which will help speed safe and effective drugs, medical devices and bio-similar biological products to patients,” a statement from the Office of Management and Budget released Thursday read.

On Thursday, the Senate began consideration of the legislation, the Federal Food, Drug and Cosmetic Act, which creates a program where certain drug manufactures pay user-fees as part of the product-review process. The bill also increases the FDA’s user-fee program related to medical technology and certain prescription drugs.

“S. 3187 also enhances the tools available to the Food and Drug Administration to address drug shortages by requiring additional early notification of potential shortages, an action the administration called for in the 2011 Executive Order on drug shortages,” the statement continues.

Senate Majority Leader Harry Reid (D-Nev.) had previously expressed interest in moving the bill quickly. Reid hopes to come to an agreement on how many amendments Senate Republicans would like to consider for the bill so the legislation can come up for a vote quickly.

The Senate version of the bill is similar to a one in the House, H.R. 5651, which the House Energy and Commerce Committee approved by unanimous consent a week earlier.

“Promoting innovation, safety and access to medicines and devices is critical to the nation’s health, and the administration supports this bipartisan legislation that contributes to this goal,” the statement said.

Based in California, Allergan first said it was considering expanding in New Jersey in November, when it was awarded a $14.9 million grant from the New Jersey Economic Development Authority through the Business Employment Incentive Program.

The company has a smaller facility in Bedminster, where it employs 20 people. The new, 93,000-square-foot facility will bring nearly 400 new jobs to the state.

The company chose the site in New Jersey because of the local talent pool in the pharmaceutical and medical device industry, as well as its proximity to hospitals and universities, said spokeswoman Cathy Taylor.

“As a multispecialty health care company, a critical component to our business is the scientific innovation derived from the work of our R&D facilities throughout the United States,” Taylor said. “The expansion of our facility in New Jersey will enable us to further enhance our product pipeline and advance our pursuit of novel medical therapies for patients.”

The facility will be part of SJP Properties’ Somerset Corporate Center campus, a series of energy-efficient office buildings in Bridgewater. Allergan’s new neighbors include Juniper Networks, Qualcomm, Merrill Lynch, Aon Consulting and Dr. Reddy’s Laboratories, SJP said in a statement.

Gov. Chris Christie heralded the news and said attracting companies to New Jersey is one of his administration’s main goals.

“Allergan’s decision to expand its operations in New Jersey will create hundreds of high-quality jobs and is proof that the pro-business policies of this administration are helping to attract and retain both large and small businesses here in the state,” said Christie. “Working diligently to attract leading companies such as Allergan to New Jersey to improve our long-term economic prospects has been a top priority of mine since I took office.”

Allergan is a global company with a presence in more than 100 countries. It focuses on several medical specialties, and also manufactures Restasis and the Lap-Band used in gastric surgery.

Three strikes and you’re out? In 2006, the FDA noticed that Acorda Therapeutics was having difficulty submitting serious and unexpected adverse event reports within 15 days of receiving such information as required by law. The same problem was observed during yet another inspection three years later. And when the FDA returned last summer, the agency found Acorda was still failing to report adverse events when required, according to a May 10 warning letter.

Acorda, however, was not just a few days late. The FDA noted there were five reports that were submitted more than 100 days past the deadline. One report described a patient who died and was due to be filed with the agency on August 28, 2010, but not received until January 10, 2011, approximately 136 days late. Other side effects that should have been reported included irregular heartbeats, arrhythmia, acute fulminant hepatitis, hypersensitivity, and memory impairment.

Just the same, Acorda is consistent, if nothing else. After the FDA issued a 483 inspection report last September, the drugmaker did send a written response. But the reply was received more than 15 days from the close of inspection. As a result, the FDA reviewed the response, but did not include its contents in its newly issued warning letters, citing an August 2009 Enforcement Initiative that was declared by the FDA commmish.

There was more, though. The FDA cited Acorda for failing to maintain adequate written procedures to ensure adverse events are detected, correctly identified, assessed, and reported to the agency. In fact, Acorda failed to maintain records of all adverse drug experiences, including raw data and any correspondence relating to adverse events, for a period of 10 years. That is a long stretch, yes?

Making matters worse, Acorda had previously promised to take corrective actions, such as hiring a new contractor to handle adverse event reporting, but the problem continue to occur. And the FDA could not find documentation to substantiate claims that Acorda, which sells the Ampyra multiple sclerosis treatment, had trained and audited it specialty pharmacy distributors.

And contractor paperwork was problematic, since Acorda did not have documents that were to have been sent from one pharmacovigilance contractor to another. “This became an issue,” the FDA wrote, when its inspector requested documents to back up claims for downgrading adverse events reports to “non-cases.” Acorda management repeatedly stated source documents were not available and the drug safety director could not find documents for some cases, the FDA writes. One example: a report that contained instructions to change “hospitalized for UTI” to just “UTI” without a rationale or justification for downgrading this report from serious to non-serious, the FDA letter states.

Meanwhile, Acorda failed to investigate an unspecified number of reports in which Ampyra was allgedly ineffective, even though the FDA notes that the Ampyra Annual Product Review for 2010 states the drug will not be effective in all patients and, therefore, a lack of efficacy is expected (here is the warning letter).

An Acorda spokesman tells us the drugmaker is “apprising FDA with regular updates, directed toward issues they raise in the letter. The inspection resulted in 483 that happened last summer… and we do believe we have addressed all the issues that have been raised.” He also says that a new pharmacovigilance contractor has been hired. The problems, he added, dated to when Acorda was “a young company growing up.” By now, though, the training wheels should have come off.

The plant is in Devens, Mass. Bristol-Myers said about 300 scientists, engineers, quality specialists and other employees work there. It said the new plant will help the company meet demand for Orencia and future products.

Bristol-Myers said it makes its biotech drugs in a facility in Syracuse, N.Y., and through deals with third-party suppliers. Manufacturing is then finished at a facility in Manati, Puerto Rico.

The FDA approved an injectable version of Orencia in July, allowing patients to give themselves the drug. Previously the drug was only given through intravenous drips.

The move was greeted with applause by critics who more often accuse the organization of wantonly adding to the list of psychiatric diagnoses that may greatly increase the number of people considered mentally ill and, therefore, eligible for psychiatric and medical treatment. The DSM, which is known as the Bible of psychiatry, is officially a reference tool, although its outsized influence stokes concerns that many psychiatrists rely too heavily on its diagnoses for guidance.

The DSM “has become the arbiter of who is ill and who is not, and often the primary determinant of treatment decisions, insurance eligibility, disability payments and who gets special school services,” Allen Frances, a former psychiatry department chair at Duke University School of Medicine who led the DSM-4 task force, wrote in The New York Times. “DSM drives the direction of research and the approval of new drugs. It is widely used (and misused) in the courts.”

Assembling the upcoming DSM-V has, meanwhile, spawned enormous controversy. For instance, the definition of addiction is being revised to include gambling and may also introduce a more general diagnosis called “behavioral addiction — not otherwise specified.” The APA maintains such moves can save health care dollars down the road, but critics say resources may be used unnecessarily to treat substance abusers who are classified as addicts.

There has also been debate about Premenstrual Dysphoric Disorder, or PMDD, and whether the affliction should be updated as a full-blown problem alongside the likes of Major Depressive Disorder or remain a diagnosis in need of further study. The head of the APA task force, which will make a recommendation, insists PMDD is a legitimate health problem and evidence exists to warrant a diagnosis (read more here).

A backdrop to the DSM-V controversy are ties between members of the various APA working groups and drugmakers, which would benefit if new diagnoses are listed or definitions expanded in ways that more medications would be prescribed. A recent paper in PLoS Medicine noted that 69 percent of the DSM-5 task force members have ties to drugmakers, which is up from 57 percent of the DSM-IV task force members (see here).

Frances disagrees. “Many critics assume, unfairly, that DSM-V is shilling for drug companies. This is not true. The mistakes are rather the result of an intellectual conflict of interest; experts always overvalue their pet area and want to expand its purview, until the point that everyday problems come to be mislabeled as mental disorders, he wrote. “Arrogance, secretiveness, passive governance and administrative disorganization have also played a role.”

This point is likely to remain a debate within a debate. Nonetheless, the wider issue remains in play. And Frances proposes that a federal agency ought to assume the job of developing the DSM, although he believes a new organization would be required, one that could be housed in the US Department of Health and Human Services, if not the Institute of Medicine or the World Health Organization. An equivalent of the FDA is needed to “mind the store,” as he puts it.

This may raise a different set of objections, of course. To what extent, for instance, should a federal agency delve deeply into determining diagnoses and definitions? On the other hand, perhaps this would remove the concerns over self-interest and conflict that have tainted the process.

Three years ago, a former Bristol-Myers Squibb senior vice president named Andrew Bodnar pleaded guilty to lying to federal authorities about a botched patent deal involving the Plavix blood thinner, an episode that contributed to an overhaul of its c-suite. As for Bodnar, a judge did something highly unusual that quickly became a wry joke – instead of throwing the book at him, he ordered Bodnar to write a book so others might learn from his alleged mistakes.

Now, the book is out…sort of. A 253-page manuscript, which was entitled ‘The First Question,’ was filed in federal court last October as part of the deal (which also included a $5,000 fine). Although his memoir may not be considered a page turner (he is no Keith Richards), Bodnar does provide some useful insights into some of the behind-the-scenes workings of the pharmaceutical industry. And he mostly does so in a confessional tone.

“He ordered me to tell my story. To write a cautionary tale. To tell others how to avoid the Gehenom (which is Hebrew and roughly means netherworld) in which I have found myself for the past five years. Thankfully, for everyone other than me, this hell is so particular, that no judge’s order could ever generalize it. And, yet, by order of the court, I must write the story. And so I have,” Bodnar writes.

The tale begins when Bodnar is traveling and receives an urgent phone call from a lawyer at Cravath, Swaine and Moore that the FBI has raided his office – and the office of Peter Dolan, who was the Bristol-Myers ceo at the time. Chaos reigns but, as I will soon learn, this is as nothing compared to the vacuum that is about to suck the air from my every breath for years to come,” he writes.

After deciding that he would not begin the book by urging readers to ‘call me schlemiel,’ the 64-year-old Bodnar proceeds to tell his version of events. The feds say he lied to the Federal Trade Commission about the arrangement between Bristol and its Plavix marketing partner, Sanofi, to keep Apotex from launching a generic version of Plavix. Bodnar writes the feds clung to a “mistaken belief that I had made a statement to the government that I knew to be false.”

Much of his recounting is inside baseball, but offers interesting glimpses into the approach taken toward generic competition and, particularly, dealings with Apotex. There is also a lot of detail concerning the government investigation and subsequent haggling over events, especially those that will determine his fate. There are also sections that review his uncomfortable dealings with New Jersey Gov. Chris Christie, who was the US Attorney at the time.

But the often-dry story is interspersed with sweet memories of his childhood and family life, which are told in third person. Notably, Bodnar recounts how his mother survived the Holocaust, the escape from Communist Hungary as the Soviets invaded in 1956 and the life of an immigrant family in the United States during an era when prosperity and achievement seemed always in reach.

Although his mother, Magda, developed Alzheimer’s, Bodnar imagines she would have told him that ” ‘at least they had to go to a judge to get a search warrant,’ continuing to make the argument she never stopped making for the ‘Land of the Free’ to which she had, at great peril and to her own well being, brought her son,” he writes. She passed shortly before he was indicted.

We asked his attorney about publication for the public, but have not heard back. We will update you accordingly. Meanwhile, if you have some free time, you can read ‘The First Question’ right here. [UPDATE: One of his attorneys wrote us to say that they "have nothing more to say about Dr. Bodnar...As you can imagine, Dr. Bodnar has moved on and does not wish to re-visit a painful part of his life.]

A key point in the debate over renewing the Prescription Drug Fee User Act, or PDUFA, has been the ability of the FDA to review drugs as quickly as possible. Along with the pharmaceutical industry, various members of Congress complain the agency moves too slowly. But a new study in The New England Journal of Medicine contradicts those assumptions and also questions whether the speed of the review process is justified as part of PDUFA reauthorization.

To wit, the study compared first and total regulatory review time among all novel therapeutic applications submitted to the FDA from 2001 to 2010. The upshot? The FDA was approximately two months faster than the other two key agencies – the European Medicines Agency and Health Canada – in issuing approvals. And the FDA was three months faster when examining a sub-sample of therapeutics that had been approved by all three agencies during this time period.

Another interesting point: among therapeutics that had been approved in both the US and Europe, 64 percent were approved for use in the US first. Among those approved in both the US and Canada, 86 percent were approved for use in the US first. As a result, the study authors contend that concerns the FDA has emphasized safety at the expense of efficient approvals is misplaced. PDUFDA, by the way, is up for renewal every five years.

“There are a lot of concerns that FDA has been slowing down, because in the last PDUFDA, safety was emphasized. And so there are concerns that safety is slowing things down,” says Joseph Ross, an assistant professor at the Yale University School of Medicine. “But there’s not a lot of data is out there. FDA issues reports on performance goals, but they’re hard to understand in context. By comparing speed with which FDA is reviewing applications with European and Canadian agencies, we have an ability to benchmark. They serve similar populations and are under similar pressures.

“I think this shows pretty clearly that FDA has not slowed down and is moving at about the exact same speed in this PDUFA period as in the last PDUFA period and, more than that, moving faster than other regulators. But what’s the right speed? I don’t know what that is or what’s right or wrong. FDA has to balance these things. But to me, I think the concerns are overstated.”

As for the numbers, the authors identified 510 applications for novel therapeutic agents, of which 225 were endorsed by the FDA, 186 by the EMA and 99 by Health Canada. Of these, 289 were unique agents. The median time the FDA took to complete a first review was 303 days, compared with 366 days by the EMA and 352 days by Health Canada. The median total review time was also shorter at the FDA. Among the 289 unique novel therapeutic agents, 190 were approved in both the US and Europe, of which 121, or almost 64 percent, were first approved by the FDA. Meanwhile, 154 were aproved by both the FDA and Health Canada, and 132, or nearly 86 percent, were first approved by the FDA (here is the abstract).

Drilling down, the FDA also outperformed the other agencies when reviewing two different therapeutic categories. For cardiovascular, diabetes and endocrine drugs, the FDA median review time was 305 days, compared with 356 for the EMA and 352 for Health Canada. The FDA trailed in total review, though, posting 365 days, compared with 356 for the EMA, although Health Canada posted 472 days.

For oncology meds, the FDA was fasted across the board. When comparing median time, the FDA took 237 days, while the EMA used 384 days and Health Canada needed 345 days. The FDA total time was 264 days, compared with 382 for the EMA and 354 for Health Canada. There were similar contrasts for respiratory and gastrointestinal drugs: median FDA time was 308 days versus 362 for the EMA and 345 days for Health Canada. Total FDA review time was 335 days compared with 362 for EMA and 345 for Health Canada.

Findings were mixed, however, for other categories. For anti-infectives, median FDA time was 275 days versus 348 days for EMA and 245 days for Health Canada. Total FDA review time was 284 days, while EMA took 348 days and Health Canada needed just 245 days. For musculoskeletal and pain drugs, median FDA time was 369 days, while EMA needed 399 days and Health Canada took 411 days. Total FDA time was 431 days versus 399 for the EMA and 478 for Health Canada.

For psychiatric and central nervous system drugs, median FDA review time was 335 days compared with 413 for the EMA and 404 for Health Canada. Total FDA time was 463 days compared with 413 for the EMA and 514 for Health Canada. For all other drugs, the median FDA review time was 303 days versus 345 days for the EMA and 378 for Health Canada. Total FDA review time was 349 days, while the EMA needed 345 days and Health Canada used 402 days.

Ross also pointed out that the study also debunks the notion that drugmakers should seek approval elsewhere first, since he and his colleagues were able to document that, for meds approved in Europe and the US, the available median time was about three months faster in the US. In other words, drugmakers “seem to be going to the agencies at the same time, but their drugs end up becoming available first in the US,” he says.

Some numbers: among 289 unique novel therapeutic agents, 190 were approved in both the US and Europe, 154 in both the US and Canada, and 137 in both Europe and Canada. Among meds approved in both the US and Europe, 64 percent were first approved in the US, with the drugs available a median of 96 days earlier in the US. Similarly, among drugs approved in the US and Canada, 86 percent were first approved in the US, and median availability was 355 days earlier in the US.

After more than a dozen years, Abbott Laboratories is no longer operating under a consent decree. The settlement was made in 1999 after a remarkable six-year run of manufacturing deficiencies and subsequent failures to fix various problems in its diagnostics division. The decree was terminated last month, according to an Abbott spokeswoman.

The move came after the drug and device maker was able to demonstrate an ability to remain in compliance with good manufacturing practices. “Many consent decrees that FDA enters with firms allow the firms, under defined circumstances, to seek court termination of the decrees following extended periods of compliance. That is the case with this one,” an FDA spokeswoman wrote us in an e-mail (here is an FDA statement at the time the decree was announced).

The termination comes at a propitious moment for Abbott ceo Miles White. The drug and device maker, you may recall, plans to split into two publicly traded companies. One will focus on devices, diagnostics, nutritionals and, outside the US, branded generics. The other will be a so-called research-based pharma that will feature a portfolio of existing meds, such as Humira and Synthroid, along with a pipeline of some 20 compounds in Phase II or Phase III development (see this).

And so, on the eve of the split, White can boast that he is a quality-driven manager and tout that Abbott, which he will continue to run, has freed itself from a burdensome and costly pact. In addition to paying a $100 million fine at the time the decree was signed in 1999, Abbott also had to avoid additional penalties for products that remained out of compliance. And there was the additional expense of maintaining a crew of consultants to ensure terms were met (here is the decree).

Meanwhile, the legacy pharma business – which will be renamed Abbvie, a nomenclature that has drawn derision in some quarters (see here) – is saddled with a freshly minted Corporate Integrity Agreement that was inked this month to resolve various probes into the marketing of its Depakote seizure med. This also involved paying a $1.6 billion fine, the second-largest such penalty to be paid by a drugmaker (you can read more here).

However, the corporate integrity agreement is the not the first to be signed since White became ceo in 1999. In 2001, TAP Pharmaceutical, a joint venture between Abbott and Takeda Pharmaceutical, paid $875 million for illegally manipulating Medicare and Medicaid in connection with promoting its Lupron prostate cancer drug. And in 2003, Abbott paid more than $600 million to resolve charges its nutritional business bilked the same government programs.

In a move that may herald a new era in fighting fat, an FDA advisory panel this afternoon voted 18-to-4 to recommend the agency approve the Arena Pharmaceutical diet pill, which is known as Lorqess. This marks the second time in three months that an FDA panel has decided the benefits of reducing the growing American waist line outweigh the various risks that have delayed this latest round of fat-fighting drugs from finding their way to medicine cabinets.

In February, an FDA advisory committee voted overwhelmingly in favor of the Qnexa diet pill developed by Vivus. Of course, the recommendations are not a guarantee the FDA will issue approvals. But the back-to-back endorsements – and lopsided votes – suggest the safety concerns that plagued the drugmakers during earlier panel meetings have been sufficiently addressed and increase the odds the FDA will approve the pills.

Unlike the September 2010 advisory panel meeting, Arena was able to overcome concerns about a theoretical risk of an increase in cancer; valvulopathy, which is heart valve damage, and cardiovascular adverse events. Some committee members discussing the possbility of requiring echocardiograms before patients are prescribed Lorqess, given that an increased risk CV events could not be ruled out. Most likely, the FDA would require a post-approval outcomes study.

A related question is whether the FDA would require a REMS, or Risk Evaluation and Mitigation Strategy. A REMS was proposed for Vivus pill, but a key issue with that drug is the risk of birth defects, which does not plague the Arena pill. Nonetheless, the FDA has been consistently cautious in viewing diet pills because these drugs are likely to be widely and, perhaps, inappropriately used, suggesting REMS programs are likely to be employed.

Nonetheless, fighting fat is a key priority for public health agencies. The percentage of obese Americans, which is already a hefty 36 percent, is expected to swell to 42 percent by 2030. And by then, 11 percent could be severely obese, which is deemed to be about 100 or more pounds over a healthy weight, compared with 6 percent two years ago, according to a study released earlier this week in the American Journal of Preventive Medicine (read here).

However, one public health advocate says the FDA bent overbackwards toward this end. Diana Zuckerman, who is president of the National Research Center for Women & Families, a nonpartisan, nonprofit think tank, says the FDA’s Center for Drug Evaluation & Research “has been under pressure to approve more drugs to reduce obesity. The pressure is from the many groups focused on reducing obesity. Their mantra has been that the risks of obesity are much greater than the risks of these drugs.”

“The consumer and public health advocates, in contrast, point out that the benefits of these drugs are very limited. Study after study show that many patients stop taking the drugs after a few weeks or months, and even those they stay on for six months or more tend to stop taking the drugs as soon as the benefits plateau. Then, they gain the weight back again. In other words, the drugs have the same long-term impact as yo-yo dieting,” she writes us.

Lorqess “did not meet the weight loss standards that FDA requires, and has risks of suicidal thoughts, neurological problems and possibly breast cancer. CDER knew their usual Advisory Committee was unlikely to recommend approval, so the agency added more clinicians,” she concludes. “The clinicians almost always want ‘more options’ and voted to recommend approval for this ineffective, possibly dangerous drug.”

“The pension changes apply to colleagues at all levels, including executives,” the spokeswoman writes. “There are some exceptions, such as colleagues hired after (January 1), 2011, as they already participate in an enhanced savings plan, rather than a pension plan; certain union colleagues based in the US, per their collective bargaining agreement; and colleagues who were part of an acquisition and are not currently earning benefits under a Pfizer pension plan.”

The plan has, not surprisingly, upset some Pfizer employees, but one could see this coming. The drugmaker is trying mightily to reinvent itself and slash costs in response to generic competition to several big-selling drugs – notably, the Lipitor cholesterol pill. For instance, Pfizer recently agreed to sell its nutritional business for nearly $11.9 billion to Nestle and is looking to sell or spin off its animal health business.

Both moves would shed numerous jobs, a trend that has been under way for several years. In fact, Pfizer has choppped some 57,800 employees since a cost-cutting program began in 2005 (see page 10 here). The effort accelerated with the 2009 acquisition of Wyeth. As reported previously, the drugmaker is in the process of slashing $1 billion in costs on top of the billions in expenses that have already been drained from operations (see here).

Of course, many companies have been eliminating or altering the terms of their defined benefit pensions plans in recent years as a way to cut expenses, a trend that has accelerated during the recent recession (here is a list of companies that, since 2005, have either terminated plans, frozen plans for new and/or current employees, or made changes to the formula by which pension benefits are calculated).