But what’s good for Ranbaxy has been causing some discomfort for FDA. Whistleblowers from FDA’s Center for Devices and Radiological Health have sued the agency over allegedly being harassed and dismissed after publicly questioning the agency’s approval methods for devices. The suit brought by the whistleblowers alleges, among other things, that FDA improperly read private emails to support a case for dismissing the plaintiffs. This prompted a letter to FDA commissioner Margaret A. Hamburg from Senator Charles Grassley, in which he castigates the agency for perceived mistreatment of the whistleblowers, and includes a series of questions for the agency to answer to clarify their actions with respect to email monitoring.

Among the questions to the agency, Grassley asks “What steps have you taken to reassure employees that they have a right to direct communications with Congress?” The answer to that question is an important one. FDA should expect no less from itself with respect to whistleblower protection than it demands of others.

They’ve also overlooked a lot of the positive aspects of the project. Deen will be offering diabetes-friendly recipes that do not comprise taste and appearing at diabetes cooking events across the US. The initiative is called Diabetes in a New Light.

But if you’re familiar with Deen’s cooking, you’ll be aware that a lot of her dishes are not exactly promotional of a healthy diet (examples include bacon cheeseburger meatloaf and southern fried chicken – you can take a look at the recipes on her website), which is where media criticism has been directed. Deen herself was also diagnosed with Type II diabetes three years ago, but only revealed this to the public this week, another aspect that has attracted criticism since she’s maintained her cooking style, despite the fact that diet is an important part of managing diabetes.

However, Deen makes a good point of saying in a press statement that “diabetes does not have to stop you from enjoying the things you love”.

At a time when obesity is rising, it’s important for us to be aware of healthy food, and chefs need to take some responsibility. Let’s be honest though, most of us don’t want to be healthy all the time, so we want to know how to make the best of our butter!

In their criticism, a lot of news sources have overlooked the contributions Deen is making to the diabetes battle. She claims to have made small dietary changes and to have worked more exercise into her day. Being a celebrity spokesperson for diabetes will also be a good influence – some sources have made snide comments about the connection between Deen’s weight, her recipes and diabetes, which will no doubt influence some people into avoiding unhealthy foods.

And with all the attention being focused on the responsibility of celebrities and chefs to promote healthy eating, Novo Nordisk and the pharmaceutical industry has gotten a bit lost. The pharma industry also has a responsibility to promote good health; indeed, this focus is becoming increasingly important in pharmaceutical business strategies as non-traditional companies, such as food and IT companies, muscle into the healthcare sector. Ernst and Young has a really good report about this trend available on their website.

Even though the diabetes campaign is partly to promote Novo Nordisk’s diabetes drug, Victoza, it’s also a step towards health education. According to one news report, many diabetes patients have trouble managing their diet. Havilah Clarke, senior manager, product communications at Novo Nordisk is quoted in the report as saying, “Based on what were hearing from some primary research we were doing, people living with diabetes thought that food was one of the most difficult challenges to address in their social lives. They thought they had to deprive themselves.”

Whatever Novo Nordisk’s intentions, it remains to be seen whether using Paula Deen will be a successful strategy given the amount of criticism the partnership has received. But there’s no such thing as bad publicity, right?

On Jan. 4, 2012, the HealthCare Institute of New Jersey (HINJ) published a press release which evaluated the results of the 2011 biopharmaceutical and medical technology economic impact survey, a study (conducted by Deloitte) which concluded that the life-sciences industry continued to make up a key sector of New Jersey’s overall economy.

Although the responses of five fewer companies—24 in the 2010 survey compared to 19 the following year—generated less meaningful findings for the most recent survey, HINJ President and CEO Dean J. Paranicas pointed to the strong continued growth in New Jersey’s bio/pharmaceutical sector. “Although we had 20% fewer companies participating in this year’s survey, those that did supply data demonstrate that the life-sciences industry continues to be a major economic driver in New Jersey,” said Paranicas. “However, New Jersey continues to face stiff competition from around the world and within the US for our industry’s investment. If anything, this data reinforces the need for our leaders in Trenton and Washington to continue to pursue policies that create a more competitive and attractive business climate here, and we look forward to continuing to work with them to achieve this objective.”

The study also cited (factoring in the decrease in participation) a total economic impact from reporting HINJ member companies of $24.2 billion in calendar year 2010, as compared to $29.3 billion in calendar year 2009.

Paranicas went on to laud the recent actions taken by Governor [Chris] Christie and the state legislature to make New Jersey more competitive and attractive for life-sciences investment. They include an aggressive and competitive business recruitment and retention program, adopting the single sales factor as the basis for calculating New Jersey’s corporate business income tax, and enhancing the Business Employment Incentive Program (BEIP) to promote greater private sector collaboration with New Jersey’s universities and colleges.

However, every rose has its thorn. The study pointed out that the number of full-time employees decreased from 55,366 in 2009 to 51,619 in 2010, and capital spending dwindled from $1.5 billion to $0.9 billion during that same span of time. The Whitehouse Station, New Jersey-based Merck & Co. announced the elimination of approximately 13,000 jobs following the second quarter of 2011 as part of a cost-cutting initiative. This continues a workforce-reduction trend for Merck in recent years. According to a July 30, 2011, article from The Wall Street Journal, “[Merck] will have eliminated about 30% of the work force it had at the end of 2009, in the wake of its $41.1-billion acquisition of Schering-Plough.”

This reflects the long-growing trend among the industry’s financially dominant companies. Expansion in the form of mergers and acquisitions (M&A), without a focused emphasis on R&D to maintain and add to a workable pipeline, will enable access to only a finite amount of prosperity constructed on a delicate foundation of borrowed time. Paranicas pointed out that global R&D spending increased by $6.1 billion—one of the factors that has contributed to the continued success of New Jersey’s biopharmaceutical sector, despite some overexpansive M&A miscalculations, and the consequences as a result.

Most of that money came out of the pockets of pharmaceutical companies. According to the release, the government recovered close to $2.2 billion in civil claims against pharmaceutical companies, including $1.76 billion in federal recoveries and $421 million in state Medicaid recoveries. Of that sum, $900 million was divided among only 8 companies, to settle allegations of unlawful pricing. GlaxoSmithKline paid out the largest single fine of $750 million, to resolve criminal and civil allegations that the company knowingly submitted, or caused to be submitted, false claims to government health care programs for adulterated drugs and for drugs that failed to conform with the strength, purity or quality specified by the Food and Drug Administration.

According to a 2010 report from Public Citizen, the pharmaceutical industry has the dubious distinction of being the largest defrauder of the US government, if measured by the number of settlements under the False Claims Act. The study found that pharmaceutical cases accounted for at least 25% of all federal FCA payouts over the past decade, with defense coming in second, at 11%. Moreover, the report found that more than half of the industry’s fines were paid by just four companies — GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough. These four companies accounted for more than half of all financial penalties over the past two decades, paying $10.5 billion in fines collectively.

Has the stepped up pace of enforcement and the increasingly large fines made Pharma better citizens? Time will tell. There’s a considerable lag between when the crime was committed, and when the crime is prosecuted. Sales practices have been reformed in recent years, and Merck’s recent settlement, for example, also included a corporate integrity agreement with HHS. While I’m all for paying down the deficit, the industry should be striving to put those settlement dollars to better use.

Last Thursday, FDA issued an interim final rule requiring manufacturers that are the only producer of certain drug products to report all manufacturing interruptions to the agency. Early notification will help FDA work with drug manufacturers and doctors to make sure that patients have access to life-supporting products. The interim rule was spurred by President Obama’s Oct. 31, 2011, executive order, which directed FDA to reduce and prevent drug shortages.

But the agency is not relying on just one tactic. In addition to the interim final rule, FDA is developing a tracking database to monitor drug shortages. The database will record the numbers of shortages, the reasons for shortages, and what steps FDA is taking to address and prevent them. The database is a high priority for the agency, which hopes to complete it in 2012.

Also, several observers have expressed concern that unscrupulous organizations could attempt to reap large profits from drug shortages. In response, FDA has begun analyzing reports about drug stockpiling and exorbitant pricing. The agency plans to provide the Department of Justice with information about these reported activities, and the Department will determine whether they are consistent with the law. This issue is on Congress’s radar, too: Senator Charles E. Schumer (D-NY) recently introduced a bill to make price gouging on scarce drugs a federal crime.

As any supply-chain professional knows, having one source of a crucial item is far from an ideal situation. If a drug is crucial but not profitable, we may not see new sources spring up to provide additional supply-chain security. But FDA’s initiatives promise to ease the threat of drug shortages and reduce patients’ suffering.

After reviewing the data, obstetricians, gynecologists, and pediatricians at the Center for Drug Evaluation and Research (CDER) determined that Plan B One-Step “was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases,” according to a statement by FDA Commissioner Margaret Hamburg. CDER also concluded “that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider,” according to the statement. And FDA is not alone—the American Academy of Pediatrics also supports over-the-counter access to emergency contraception.

Sebelius’s concern about the ostensible lack of studies including 11-year-olds seems unusual when one considers that many over-the-counter drugs have not been studied in preadolescents—and some are far more dangerous than Plan B One-Step. “Acetaminophen can be fatal, but it’s available to everyone,” Susan Wood, a former FDA assistant commissioner, told The New York Times. “So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?”

FDA places great emphasis on scientific data, as any manufacturer contemplating a process change well knows. In this instance, FDA’s informed decision seems to have been overruled for reasons other than scientific ones.

Also see Christopher Allen and Angie Drakulich’s sidebar “Behind the Counter.”

Drug companies, including Pfizer, are wooing insured consumers by offering copay coupons, which reduce the amount of money that the latter must spend for a branded drug. These coupons are intended to discourage a patient from switching to a generic therapy. To redeem the coupons, consumers often must submit personal information that allows the firms to promote products to individual patients.

The coupons may help consumers, but they oblige plan sponsors, such as employers or state governments, to pay high prices for branded drugs when generic alternatives are available. Drug companies can prevent plan sponsors from knowing when enrollees have redeemed the coupons by processing them through a “shadow claims system,” according to a statement from the Pharmaceutical Care Management Association. Copay coupons will increase costs for these sponsors by $32 billion over the next decade, according to research from Visante.

At a time when state governments and private companies are pinching pennies, it’s hard to believe that they will allow drug companies to use these tactics for very long. Arrangements such as Pfizer’s agreement to manufacture generic Lipitor for Watson, in exchange for a share of net sales, seem comparatively more benign. Deals like this don’t appear to constrain patients’ choice or force payors to spend more than necessary for a given drug. They might be the “least bad” option for drugmakers without new blockbusters on the horizon.

Companies have been waiting in the wings to pick up the rights to the generic version. Watson Labs launched an authorized generic version of Lipitor on Nov. 30. Under the terms of an exclusive supply and distribution agreement, Pfizer will manufacture and supply Watson with all dosage strengths of the authorized generic product, and Watson will market and distribute the product in the US. In turn, Pfizer will receive a share of the net sales.

Ranbaxy Labs picked up last-minute approval from FDA to market generic atorvastatin in the US under the coveted first-to-file spot, that gives them a 180-day period of marketing co-exclusivity that they will share with Watson. The drug will be manufactured by Ohm Laboratories in New Brunswick, NJ, according to the FDA release.  According to Ranbaxy’s press release , a portion of the profits from sales of atorvastatin during Ranbaxy’s 180-day first-to-file exclusivity period will be paid to Teva, but further details of that agreement have not been disclosed.

Pfizer does not seem willing to jump quietly off the patent cliff. In an effort to maintain market share and promote brand loyalty, it has stepped up marketing in recent months, and is offering rebate coupons to insured patients to bring copays for the branded version in line with those for generic versions. It has also entered into controversial agreements with some pharmacy benefit managers in which they will receive rebates if they block generic prescriptions, a move that has sparked concern among members of Congress.

Because this particular drug has such a huge market, there’s a lot of money at stake. Generics are low margin, but low margins on a high-volume product can still make handsome profits. In developing countries, branded generics are popular, because they give patients the comfort of brand-name recognition, and an expectation of quality greater than that from nonbranded generics. That model has never caught on in the US, but Pfizer’s attempts to hold on to such a lucrative product makes me wonder whether its time will come.

Citing interviews with stakeholders, GAO recommended creating an information clearinghouse, through which companies could share information anonymously on adulterated ingredients with FDA and other companies. A clearinghouse could help FDA disseminate information about adulterated products quickly and enable the agency and industry to respond to adulteration rapidly. If the clearinghouse were managed by a neutral third party, it could ensure that the information did not identify specific companies.

This strategy could help allay industry’s concerns about sharing information when an adulterated ingredient has not entered into commerce. Companies are afraid that they may be sued if they reported that a supplier intentionally adulterated a product and the accusation is later found to be baseless. A wrongful accusation “can have serious consequences, such as compromising the integrity of the company’s brands and products if certain information became public,” according to the report.

Because potential adulterants often are unknown or unidentified, it can be hard for FDA to detect them. “For example, during the heparin incident, the available test methods for heparin were not able to detect the contaminant oversulfated chondroitin sulfate,” said the report. “Industry may be the best source of tests to detect adulteration because companies develop such tests to monitor the products they receive from their suppliers; however, industry officials indicated that they are often reluctant to share such information because it is proprietary.”

By eliminating details that could identify specific pharmaceutical companies, an information clearinghouse could allay industry’s concerns, help FDA dedicate its resources efficiently in the event of potential adulteration, and protect citizens from ingesting harmful drugs. It sounds like a win for all involved. GAO has done us a service in writing this report, and I hope FDA takes its recommendations seriously.

After reviewing its documentation, the company concluded that routine preventive maintenance and requalification of manufacturing equipment at the site was overdue. Ben Venue suspended manufacturing so that it could assess the entire site and take appropriate corrective actions to ensure the safety of its products. The suspension will affect Johnson & Johnson, which markets Doxil, as well as Pfizer, Hospira, and Teva.

Last month, President Obama ordered FDA to take various steps intended to prevent and reduce drug shortages. The agency will require advance notice from manufacturers likely to face manufacturing disruptions, and it will expedite reviews of new drug suppliers, production sites, and manufacturing changes.

These steps, while helpful, do not address an important factor that contributes to drug shortages: manufacturing deficiencies. Even before Ben Venue conducted its own review, FDA found 48 quality concerns during an inspection of the Bedford site in May 2011. FDA likely needs a larger pool of inspectors to oversee drug manufacturing sites more thoroughly. But the government’s current desire for austerity will probably preclude the budget increase that would make hiring possible.

Maybe FDA should prioritize manufacturing sites for inspection if they are among a few that produce a medically necessary drug such as Doxil. Greater attention to crucial sites could identify problems earlier and, ideally, resolve them without disrupting drug supply.