Last year, a publication in the UK called Future Prescriber ran an article written by two physicians that touted the virtues of Trajenta, a treatment for Type 2 diabetes that Boehringer Ingelheim and Eli Lilly were about to jointly market in Europe. However, there were some problems with the article, which prompted a general practitioner to complain about a host of exaggerations and misleading statements.

How did this happen? The article is the latest example of a drugmaker and a publication working together to promote a medication in a way that can cause the average practitioner to get the wrong impression about the safety, effectiveness or cost of a drug, according to the Prescription Medicines Code of Practice Authority, which reprimanded Boehringer for several breaches of the code

In short, Boehringer was chastised for going overboard, since the drugmaker and the publisher agreed on the topic and agreed to purchase 2,000 reprints. According to the PMCPA, the original proposal stated the article would be independently commissioned, peer reviewed and published within the main pages of the journal. And there would be no input from Boehringer other than for medical accuracy.

“For the company to consider it anything other than a promotional item demonstrated a serious lack of understanding of the (PMCPA) code. High standards had not been maintained and ruled a breach of the code. The (PMCPA) panel considered that Boehringer Ingelheim’s involvement with the publication brought discredit upon and reduced confidence in the pharmaceutical industry,” the PMCPA wrote.

What was wrong with the article? The list is long. In no particular order, Boehringer was mentioned only at the bottom of the article, obscuring its involvement. The doctor who complained noted that the authors of the article had previously received support from both drugmakers. The article also incorrectly stated that Trajenta was approved in the UK and ready launch. At the time, the drug had received a positive opinion from the European Medicines Agency, but was not actually approved.

This is a key point, by the way. The doctor who filed the complaint with the PMCPA, which is a voluntary industry organization, charged that the decision to underwrite and promote the article, and the alleged lack of scrutiny to various statements offered as fact actually suggested that the drugmakers “were keen to promote Trajenta prior to (marketing) license” by regulators.

Getting back to the list of problems: the title and the body of the article both incorrectly suggested Trajenta represented a new class of DPP-4 inhibitors, a type of diabetes meds, and the article also incorrectly suggested the drug was safer to use than a rival med, Onglyza.

Lilly, however, was given a pass. The PMCPA determined that the drugmaker was not aware of the article until it was contacted by Boehringer Ingelheim, since the chain of events purportedly occurred before their marketing alliance was agreed upon. “Given the exceptional circumstances the panel did not consider that Lilly was responsible for the article at issue, and ruled no breach of the code,” the PMCPA decided.

Here is the ruling.

Between 2000 and 2009, Pfizer stock did not fare so well. As this chart indicates, the shares began the decade hovering around $45, but then dipped to below $14. And so a group of Pfizer employees have filed a lawsuit against the drugmaker, claiming their retirements plans took a beating because these held a disproportionate amount of Pfizer stock.

During that stretch, you may recall, Pfizer paid big bucks to swallow up some of its biggest rivals - Warner-Lambert and Pharmacia - in order to gain some key medicines. But the Pharmacia deal, in particular, was followed by controversy over the safety of the Celebrex and Bextra painkillers, which were similar to Vioxx. Bextra, in fact, was eventually withdrawn from the market.

The employees also argue that Pfizer stock was hurt by sales and marketing practices that eventually resulted in a $1.2 billion fine paid and a felony plea to settle an investigation into what the US Department of Justice called fraudulent marketing of several drugs. And so, the employees say Pfizer officials breached their fiduciary by not recognizing the extent to which these developments, among others, were significantly contributing to a significant loss in value of Pfizer stock and their plans.

The “defendants knew or should have known that Pfizer stock was an imprudent investment at all times during the… class period, because the company was engaging in undisclosed risky and improper activities in relation to its prescription drugs, including Celebrex and Bextra, which artificially inflated the value of company stock,” according to the lawsuit, which was filed in federal court in Puerto Rico.

More specifically, the employees say that there was an “over concentration” of Pfizer securities held in various retirement plans managed by the drugmaker and its proxies. As an example, as of December 31, 2006, the Pfizer Stockholder Plan for employees in Puerto Rico had total assets of approximately $83.6 million, of which approximately $48 million was invested in Pfizer common stock. That works out to roughly 57 percent. This plan, by the way, was just one of several employee retirement plans that were cited in the lawsuit as holding similar proportions of Pfizer stock and suffering subsequent losses.

“This investment strategy proved to be disastrous. When information emerged publicly in 2004 concerning safety concerns associated with Pfizer’s blockbuster drugs Bextra and Celebrex, Pfizer stock fell by approximately 24 percent, causing hundreds of millions of dollars in losses to the plans,” according to the (the lawsuit).

A Pfizer spokesman send us this statement: “We have not yet been served with this complaint. Based on our preliminary understanding, this case appears to be a reassertion of claims that were previously dismissed in a different court. We intend to defend vigorously any new assertion of these claims.”

Months after we asked whether James Murdoch should remain on the GlaxoSmithKline board (back story), the embattled scion of the Murdoch media empire has decided not to stand for re-election at the upcoming annual shareholder meeting to be held this May. At least, that is the wording in an official statement released this morning by the drugmaker.

His three-year stint as a non-executive director has been under a cloud ever since a scandal erupted over charges that various employees in the Murdoch media empire in the UK hacked into phones belonging to families of murder victims, terror victims, police and politicians. Ironically, one of the two committees that Murdoch will be departing is the corporate responsibility committee, which usually implies a board member knows something about being a good corporate citizen (see here).

His tenure may also have become a bit of an embarrassment for Glaxo, especially since he also sits on the remuneration committee, which means that he is one of a select few who gets to decide such matters as the compensation that is given to Glaxo ceo Andrew Witty. And just last month, Witty - we mean Sir Andrew - was knighted as a member of the Order of the British Empire, which has not been pleased with the Murdoch clan (see this).

The younger Murdoch, you may recall, has been criticized and second-guessed ever since he offered his version of the sordid events. As deputy chief operating officer of the empire built by his father, Rupert, he has had to defend himself against charges that senior execs at his UK newspaper operation knew that hacking was going on for quite some time.

When we first raised the subject last summer, a Glaxo spokeswoman wrote us to say that “the full facts must be established and the ongoing investigations be allowed to take place and come to a considered conclusion” before the drugmaker may consider any steps. In other words, there was not going to be a rush to judgment. Now, though, the situation may have grown, shall we say, distracting.

As noted previously, the Glaxo board could use a few directors who can offer useful guidance not just about strategy, but also for conducting affairs in a way that enhances corporate standing and builds needed relationships with shareholders, government, partners and patients. In late 2010, Glaxo paid a hefty $750 million fine to settle charges over production problems - contaminated meds, mislabeled packaging and incorrect dosages - at a facility in Puerto Rico and the feds say the investigation is ongoing (see this). The drugmaker also agreed to pay $40.8 million to 37 US states and the District of Columbia as well.

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 our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Savient Pharmaceuticals promoted Stephen Smolinski to vice president of marketing. Before joining the drugmaker, he was a marketing director at Roche, where he launched the Actemra rheumatoid arthritis treatment. He previously worked for Johnson & Johnson and Bristol-Myers Squibb.

And we have another winner. Blueprint Medicines hired Christoph Lengauer as chief scientific officer. He was previously vice president and global head of oncology drug discovery and preclinical development, and before that, Lengauer was executive director and senior unit head for oncology discovery at the Novartis Institutes for Biomedical Research.

Medistem added Alan Lewis to its advisory board;
Bristol-Myers Squibb added Gerry Storch to its board;
Formula Pharmaceuticals added Martyn Greenacre to its board;
Sirona Biochem hired Sean Cunliffe as chief business officer;
ICON added Brendan Buckley and Nicholas Alp to its scientific council;
Boehringer Ingelheim promoted Paul Fonteyne to US ceo and president;
Coldstream Labs hired Sholto Maclean as technology transfer manager;
Cerulean Pharm hired Chris Guiffre as sr vp and chief business officer;
Celgene added Richard Barker to its board;
Rapid Pathogen Screening hired Mark Myslinski as ceo;
La Jolla Pharma named George Tidmarsh as ceo and president;
Ventrus added Anthony Altig to its board;
Tris Pharma named Mahdi Fawzi as exec vp of R&D and chief scientific officer;
Pfizer Animal Health promoted Scott Webster to head the Improvest team;
Jazz Pharmaceuticals hired Suzanne Sawochka Hooper as general counsel;
Jazz Pharmaceuticals named Fintan Keegan as sr vp of technical operations;
Jazz Pharmaceuticals named Eunan Maguire sr vp of strategy and corp development;

And now, a separate section just for Novartis…

Novartis named Charlie Hough as strategy head, corporate social responsibility;
Novartis named Michele Galen as head of communications;
Novartis named Jason Browning as head of global internal communications;
Novartis named Eric Althoff head of global external communications;
Novartis named Vas Narasimhan as global head, vaccines development;
Novartis named Brent MacGregor as vaccines head for North America;
Novartis named Carsten Schroeder as global head, diagnostics;
Novartis named Johanna Pattenier as head of public health and market access;
Novartis named Tim Wright as global head of development;
Novartis named Lutz Hegemann as head, global development franchise, established meds;
Novartis named Laurie Letvak as head, global development franchise, critical care;
Novartis named Patrice Matchaba as global head, development operations;
Novartis named Rob Kowalski as head of global development for the US;
Novartis named Miles Harrison as head of global advocacy;
Novartis named Teresa Jose as cfo for Novartis oncology;
Novartis named Alfred Bein is as head of primary care for Europe;
Novartis named Charles Meng as general counsel and chief compliance officer in China;
Novartis named David Lennon as chief marketing officer in China;

Ladder shot thx to Robert CB on Flickr Creative Commons

And so, yet another working week will soon draw to a close. As you know, this gives us permission to daydream about weekend plans. We have a very modest agenda, though. A little exercise, a few naps and catching up on some reading. And you? Anything interesting planned? Perhaps, this is an opportunity to spend a few moments with someone special or tidy up around your lily pad. Or as the Republican primary has reminded us, the time is nearly at hand to ready your taxes. Whatever you do, have a grand time, but be safe. See you soon…

European Parliament Rapporteur Quits In ACTA Protest (BBC)

EU Ends Procedural Case Into Servier (Bloomberg News)

Why Biogen Got Out Of Corporate Venture Capital (Xconomy)

Ranbaxy Gives Up 180-Day Exclusivity On Which Drugs? (Bloomberg News)

J&J Wins Trial Over Levaquin Side Effects (Bloomberg News)

Active Ingredient In Viagra Shrunk Disfiguring Growth In Kids (HealthDay)

Pakistan Probes State Officials And Pharma Contracts Over Deaths (The Nation)

Merck Urges Thailand To Direct Scientists Into R&D (Bangkok Post)

Amgen Misses Profit Estimates On Plunging Anemia Med Sales (Bloomberg News)

Bristol-Myers Profits Fall Short Of Wall Street Forecasts (Associated Press)

EDITOR’S NOTE: Please check this post for updates throughout the morning

pic thx to morristownnps on flickr

Three months ago, Par Pharmaceutical filed a lawsuit against the FDA contending that its right to convey “truthful” information to physicians is protected by the First Amendment, yet is thwarted by agency regulations governing off-label promotion (here is the lawsuit). At issue, the drugmaker argued, was its ability to talk to doctors who may prescribe one of its drugs for unapproved uses.

In particular, Par was referring to Megace ES, which was approved by the FDA in 2005 to treat anorexia, cachexia or unexplained weight loss in AIDS patients. However, Par did not dispute that some doctors prescribe Megace to treat wasting in other patients, such as the elderly or those with cancer. In fact, the US Attorney in New Jersey is investigating its sales and marketing practices.

The lawsuit was the latest missive by the pharmaceutical industry to attack FDA regulations governing drug promotion - notably, off-label marketing - and claim that such efforts constitute protected speech. Drugmakers are testing this argument the wake of a US Supreme Court ruling last year that struck down a Vermont law about data mining (see here).

Earlier this week, however, the FDA filed a response to the Par lawsuit and excoriates the drugmaker for various positions articulated in its complaint. Specifically, the FDA maintains that Par is incorrect to argue that the agency would seek to press off-label marketing charges that would be based on hypothetical arguments, especially if the drugmaker adheres to the law and refrains from such illegal promotion. Put another way, the FDA maintains the case is not ripe.

“This case is not justiciable because Par does not face a credible threat of prosecution for the future course of conduct alleged in the complaint,” the FDA writes. “Par’s argument rests on a patchwork of false assumptions and misinterpretations of the regulations, and if Par confines itself to the marketing plans and activities specifically alleged in the complaint, it has no reason to fear prosecution on that basis… Par cannot fabricate a justiciable controversy by wrongly anticipating agency action based on a misreading of FDA’s regulations and claiming a need to assuage self-induced
fears.”

Not surprisingly, the FDA also argues that Par is fundamentally wrong to insist its ability to discuss its drugs is crimped - if off-label promotion occurs. “The challenged FDA regulations are fully consistent with the Federal Food, Drug, and Cosmetic Act and the First Amendment, and leave ample room for Par to engage in truthful and non-misleading speech about the approved use of its product,” the FDA continues. “Whatever interests Par may assert are far outweighed by the government’s paramount interests of protecting the public health by ensuring the safety and effectiveness of drugs for their intended uses.” In short, off-label promotion stands as a justifiable reason for prosecution.

But there is more. The FDA then argues that Par brought its lawsuit in a not-so-veiled attempt to derail and undermine the investigation by the US Attorney. As the agency notes, Megace ES has been approved since 2005, but Par never followed-up its own efforts to seek additional indications for the drug, which might have allowed for marketing to cancer or geriatric patients.

To make that point clear, the FDA attached a declaration to its brief from Rachel Sherman, the associate director of medical policy and director of the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research, along with minutes from various meetings in 2005 between Par and the agency in which suggestions were made for reworking a clinical trial to gain wider approval (here is the FDA brief).

Meanwhile, the FDA also notes in its brief, that Par has admitted to speaking about approved uses to “potentially off-label prescribers” in certain settings, including oncology and long-term care facilities for the elderly. And at the same time, the agency points out that Par maintains that its reps do not speak about approved use to off-label prescribers in settings targeting elderly or cancer patients.

“But there is no principled distinction to be made between these activities in these two settings,” the agency argues. “Whatever Par’s reasons for choosing to promote in one setting but not the other, it was not chilled by a fear of prosecution, and Par’s alleged harm is self-inflicted and unnecessary. Nor has Par explained why, if its fear is real and its motivation is to clarify its First Amendment rights, it waited until this late hour to file suit - after marketing Megace ES for six years, and without any intervening change in the governing regulations or FDA’s statements about how it interprets them.”

In short, the FDA is arguing that Par acted prematurely and is using the newly emerged debate over off-label promotion and protected free speech to avoid the threat of criminal prosecution. “If and when that investigation leads to any enforcement action against Par, the government’s case will rest on the full range of evidence regarding Par’s past conduct that has been developed in that investigation. Par will be free to assert any constitutional defenses to such an enforcement action in the course of that proceeding.”

One regulatory expert says the scenario is reminiscent of a case involving Allergan, which paid $375 million and pleaded guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses. The drugmaker also paid $225 million in fines to cover civil claims asserted by the DOJ under the False Claims Act (back story).

As part of the deal, however, Allergan was required to dismiss its First Amendment lawsuit (here it is) in which the drugmaker sought to win the right to distribute information about unapproved uses for Botox in the context of providing scientific and medical info to doctors. Allergan claimed an FDA ban on off-label marketing violated its First Amendment rights to free speech.

“I see this in much the same way as the Allergen lawsuit,” says Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer. “I always thought that case was an effort to gain leverage in the negotiations. Allergan paid $600 million, but it’s hard to know if the lawsuit actually made a difference.

“In any event, I think the government has done a very effective job (in the Par brief) of saying ‘Look, whatever is going on in that investigation is all well and good, but that’s not what this case is about.’ And, according to FDA, it’s not a ‘case or controversy’, in any event, because what Par is saying it wants to do is not a violation of law. According to FDA, if all that the company wants do is what it lays out in its complaint, then that’s not a problem by itself. But if there’s some other scheme we don’t know about, then FDA, according to the brief, reserves the right to examine that separately. But based on what’s in the Par Complaint, FDA says it won’t prosecute. So what’s the big deal?”

“I think government is right on this point. I think this is an effort by Par to gain leverage in the DOJ investigation. On the other hand, I think the government makes a very strong case that there’s no controversy here… As FDA notes, if Par is shivering because it perceives a ‘chill’ in its First Amendment rights, that shivering is for its own reason, but not because Par risks any appreciable danger of prosecution for the limited activities in lays out in its complaint.”

pic thx to newtown graffiti on flickr

Here is a case where the glass is either half full or half empty. A new survey finds that 51 percent of adults in the US access some type of information about medicines and health issues on a web site or mobile app that is sponsored by a drugmaker. Among the topics being explored: info about specific conditions, disease management and treatment, and guides for having discussions with doctors.

From there, 43 percent of those who accessed a web site, a tablet or app sponsored by a drugmaker then talked to their healthcare provider about prescription drugs, according to Manhattan Research, a market research firm that queried 6,634 adults last fall. Ironically, the survey was conducted online, yet only half of the respondents go online for prescription drug or health info.

In any event, the survey found that consumers rely more on these portals when they suffer from a chronic condition. For instance, 75 percent of angina patients and 72 percent of bipolar disorder patients tap those resources. Similarly, 68 percent of rheumatoid arthritis patients and 51 percent of people with high blood pressure go online to gather information.

“The bottom line was that, once the consumer is interacting with one of these resources, we saw that they took some kind of action, particularly bringing up prescription information with their doctor,” says Maureen Malloy, a senior healthcare analyst at the market research firm. “For pharma, there’s a strong opportunity to provide more tools to faciltate discussion with doctors.”

You can get all sorts of things when you pay $2.9 billion for a biotech, including an admonition from the FDA. That’s what happened to Celgene last month, when the FDA issued a stern letter for a troublesome white paper that Abraxis BioScience had distributed at the American Society of Clinical Oncology meeting nearly two years ago.

The subject of the white paper was Abraxene, an injectable med used to treat metastatic breast cancer and a key reason that Celgene bought the biotech in late 2010. However, the paper broadened the indication for Abraxane, made unsubstantiated effectiveness and superiority claims, and omitted and minimized important risk information associated with its use. As a result, misbranding occurred.

There were other problems. For one, the paper promoted Abraxane as safe and effective for additional uses for which it is being studied. The paper was disseminated at ASCO without the full FDA-approved product labeling. And Abraxis failed to submit the paper in advance for FDA review. And if you were wondering how the FDA knew, well, a staffer grabbed a copy from the Abraxis booth in the exhibit hall.

This caused another big problem. Why? In November 2010, after Abraxis was purchased, Celgene responded to an FDA query asking about the paper, which was published in Drug Delivery Report. The drugmaker indicated the publication is not peer-reviewed, but the paper was restricted to individual requests by people with “clear business interests” in similar products or third-party relationships.

Here’s the kicker: The FDA maintains that Celgene “alleges that the white paper was not made available to the conference’s primary audience (physicians or others involved in the decision process for treating patients) or to the commercial sales force.” But the FDA staffer found the paper on the countertop at the Abraxis booth during exhibit hours, where anyone could get a copy.

The representative from the FDA Office of Prescription Drug Promotion “was neither approached by an Abraxis representative when the white paper was obtained nor was a PL (product labeling) offered or attached to the piece,” the FDA office writes to Celgene in a December 23, 2011, letter.

In other words, someone got their facts wrong… at best. The lesson? Next time a drugmaker wants to distribute an off-the-reservation white paper, it should not be left in plain view at a medical conference where FDA staff are snooping. Or just refrain from distributing a paper at all until the agency has given its blessing. One more thing: get your story straight before talking to the FDA.

Here is the letter to Celgene from the FDA OPDP staff.

Good morning, everyone, and how are you today? As usual, we are scurrying about in hopes of delivering the short people to their various schoolhouses. So far, so good. Nonetheless, there is much to do. So, while we quaffe a cup or two of delicious stimulation - we are back to Southern Pecan - please enjoy the items we have assembled below. We hope these get you off to a good start. Meanwhile, have a great day and keep in touch…

Amphastar Is Granted A Stay In Lovenox Case Against Momenta (Bloomberg News)

Amgen To Aquire Micromet For $1.2 Billion (Bloomberg News)

Studies Reignite Debate Over Avastin For Breast Cancer (MedPage Today)

Illumina Plans Poison Pill To Thwart Roche Bid (Bloomberg News)

Celgene Buys Avila Therapeutics For $350 Million (Xconomy)

Hepatitis A Vaccine Rates In The US Vary Widely (Reuters)

The Effient Launch Was Worse That It Looked (RPM Report)

West Virginia Bill Pushes Rx-Only Status For Pseudoephedrine (Charleston Daily Mail)

EU May Force API Suppliers To Verify Starting Materials (InPharma Technologist)

Covance Shocks Wall Street With IT Investment Plan (Outsourcing Pharma)

EDITOR’S NOTE: Please check this post for updates throughout the morning

Filing false data with the FDA can cause problems. Just ask Ranbaxy Laboratories, which last month agreed to pay a $500 million fine and accept a consent decree for a raft of manufacturing violations (back story). Now, the US Department of Justice has released more details - the feds have filed a consent decree for a permanent injunction that prevents the Indian drugmaker from making meds for the US market until certain facilities meet US standards.

In announcing the consent decree, the feds are calling the move unprecedented. “This action against Ranbaxy is groundbreaking in its international reach – it requires the company to make fundamental changes to its plants in both the United States and India,” Tony West, Assistant Attorney General for the Justice Department’s Civil Division, says in a statement.

The Indian plants that West refers are located in Paonta Sahib, Batamandi and Dewas, which were placed on an FDA import alert in 2008. The US facility was based in Gloversville, New York, but has already been closed. However, other Ranbaxy facilities are not covered by the consent decree, notably a Princeton, New Jersey, plant that makes generic Lipitor.

What kind of problems did the feds find? The list is long: a failure to keep written records showing that drugs had been manufactured properly; a failure to investigate evidence indicating that drugs did not meet their specifications; a failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; a failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date, according to the feds.

Moreover, Ranbaxy submitted false data in drug applications to the FDA, including backdating tests and submitting test data for which no test samples existed. These actions violated the federal Food, Drug and Cosmetic Act, which meant many Ranbaxy drugs were adulterated, potentially unsafe and illegal to sell in the US, the feds say. The fabricated bioequivalence and stability data, by the way, 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 (back story).

So what does Ranbaxy have to do? The drugmaker, which is now owned by Daiichi Sankyo, must remove false data contained in past drug applications and, of course, not submit any more false data to the FDA. So Ranbaxy must hire an outside expert to conduct an internal review at the affected facilities and audit applications containing data from those facilities; withdraw any applications found to contain false data; set up a separate office of data reliability, and hire an outside auditor to audit the affected facilities in the future, the feds say.

Meanwhile, Ranbaxy has agreed to relinquish any 180-day marketing exclusivity that it may have for three pending generic drug applications, and the drugmaker has also agreed to relinquish any 180-day marketing exclusivity that it may have for several additional generic drug applications - if it fails to meet certain decree requirements by specified dates, according to the FDA.

Three Ranbaxy execs were also named as defendants, by the way. They are: Dale Adkisson, senior vice president, head of global quality; Arun Sawhney, chief executive officer and managing director, and Venkatachalam Krishnan, who is regional director for the Americas.

There are exceptions for making drugs in the US, however. These include making meds to be used in clinical trials under investigational new drug applications or for bioavailability or bioequivalence testing. Ranbaxy can also make limited quantities for preparing or supporting an drug application to the FDA or meds specifically for conducting “non-clinical laboratory studies” or other research and testing that does not involve human subjects. And finally, Ranbaxy can distribute drugs that are made by third parties or meds that do not require any manufacturing activities.

[UPDATE: Despite the restrictions, one industry observer says the consent decree does not go far enough. "When the US government came knocking, Ranbaxy lied about it and dragged its heels, causing unknown danger to the world's sickest and poorest HIV/AIDS patients. Now the company is being allowed to merely pay a fine and have its facilities reinspected and audited by a third party? That's it? No one is going to jail?" says Patrick Burns of Taxpayers Against Fraud, a non-profit.

"Why has this generic foreign drug manufacturer not been permanently excluded from doing business with the US government, especially since it has been bought by Japanese drug manufacturer Daichi? Allowing the Ranbaxy brand to return to America's store shelves under any circumstances is a major mistake. If we wink at this kind of abuse, we might as well walk around the global pharmaceutical marketplace with a giant 'Kick Me' sign on our back."]

The decree, which remains subject to court approval, does permits FDA to order additional Ranbaxy facilities to be covered by the decree if the agency discovers through an inspection that the facility is not operating in compliance with the law and/or has serious data integrity issues, an FDA statement says.

Here is the consent decree for the permanent injunction and here is the complaint filed by the Justice Department.