First, Pfizer recently told employees that severance packages would be reduced as of mid-May. Now, the big drugmaker plans to eliminate its defined benefit pension plan as of 2018 and will direct employees to funnel their money into a 401K investment account, according to a company memo. And the pending changes will apply to all employees, including the c-suite crowd, a Pfizer spokeswoman tells us.

“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).

lost money pic thx to thethreesisters on flickr

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 Watson Pharmaceuticals hired Marc Lehnen as senior vp of global integration management, a newly created position. He joins the drugmaker, which is acquiring Actavis, from McKinsey & Company, where he spent 10 years. Before that, Lehnen was a research fellow and assistant teacher at the Institute of Business Administration and Organizational Design at the University of Cologne.

BioMarin hired Dan Spiegelman as exec vp and cfo;
Novo Nordisk US hired Robert Clark as vp regulatory affairs;
Antisense Pharma hired Philippe Calais as ceo;
InnoPharma hired John Deighan as cfo;
Incline Therapeutics hired John Tucker as chief commercial officer;
AMAG Pharmaceuticals hired William Heiden as ceo and president;
Egalet hired Bob Radie as ceo;
Johnson & Johnson named Stuart McGuigan as cio;
Celgene named Thomas Moriarty as general counsel;
Advanced Cardiac Therapeutics hired Bill Olson as ceo and president;
Advanced Cardiac Therapeutics added Oern Stuge to its board;
Advanced Cardiac Therapetuics hired Miriam Taimisto as vp of R&D;
Cellceutix hired Syracuse University basketball coach Jim Boeheim as an advisor;
Watson Pharmaceuticals promoted Lisa DeFrancesco to vp, global investor relations;
Albany Molecular Research added William Marth to its board;
Amakem named Steve Pakola as chief medical officer;
Amakem added George Lasezkay to its board;
Rxi Pharma hired Geert Cauwenbergh as ceo;
Tonix Pharmaceuticals added Samuel Saks to its board;
Tris Pharma hired Amanda Wohlleber as vp of scale up & technical services;
Tris Pharma promoted Rajul Parikh to vp operations;
Teva Pharmaceuticals says former Cephalon coo Kevin Buchi and R&D head Lesley Russell have left;
Teva Pharmaceuticals hired Michael Hayden as president of global R&D & chief scientific officer;

Ladder shot thx to Robert CB on Flickr Creative Commons

And so, another working week is about to draw to a close. Not a moment too soon, yes? As you know, this is our treasured signal to daydream about weekend plans. And this is a special weekend on the Pharmalot corporate campus, because Mrs. Pharmalot is celebrating a special birthday. In fact, we will be rolling our sidewalks in early today in order to prepare and are leaving our esteemed colleague, Chris Truelove, in charge of trolling for interesting items. That said, we will be back, as usual, on Monday. As for you, we hope you have a grand time, whatever you do – a walk in the park, a cozy moment with someone special or, perhaps, a shopping spree to bolster what is left of our economy? Indeed. Meanwhile, here are some tidbits. And don’t forget to say hi to mom…

Cardinal Health Set For Showdown With DEA Over Pain Pills (Bloomberg News)

FDA Panel Backs Gilead Pill For HIV Prevention (Bloomberg News)

Merck Serono Workers Threaten To Strike Over Layoffs (World Radio Switzerland)

FDA Voices Caution About Popular Bone Drugs (New York Times)

PDUFA Bill Sails Through House Committee Vote (Regulatory Focus)

Washington State Declares A Whooping Cough Epidemic (Washington Post)

European Patient Group Demands Action On Off-Label Safety (Pharma Times)

Indian Minister Complains Of Anti-Generics Smear Campaign (InPharma Technologist)

AMAG Pharma Is No Longer Considering A Sale (Associated Press)

UK’s NICE Backs Allergan’s Botox For Some Migraine Patients (Dow Jones)

A Look At Rebates For Top-Selling Drugs (Forbes)

Merck Win In Australia Over Vioxx Liability Is Upheld (Bloomberg News)

EDITOR’S NOTE: Please check this post for updates

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.”

scale pic thx to alan cleaver on flickr

The ongoing battle over compulsory licensing may appear arcane or simply complicated to many people, but the issue was responsible for a fair amount of buzz this past week, at least as far as drugmakers go. The buzz began after Bayer challenged a license that was awarded recently by India’s Patent Office to Natco, a generic drugmaker, to make a copy of its Nexavar cancer med (see here).

The move prompted Cipla, another Indian generic drugmaker, to lower prices of three cancer drugs by 80 percent, making them cheaper than the Natco version. In reponse, Bayer charged Cipla violated its patent rights. Consequently, Cipla garnered more buzz than any other drugmaker in recent days, according to Semantelli, a market research firm that tracks social media in the pharma world and provides us with a weekly buzz installment.

Beyond the growing spat in India and the implications for pricing, Covance generated a substantial amount of buzz after disclosing plans to close a toxicology testing facility in Arizona that was opened only three years ago, but suffered due to decreased demand, primarily from Amgen. Investors were dismayed because the move also signaled the potential for still more cuts. The plant, by the way, had drawn protests from animal-rights groups (see this).

What else caused drugmakers to land on the social media radar screen? A biosimilar deal between Daiichi Sankyo and Coherus Biosciences; the $1.6 billion paid by Abbott Laboratories to settle various government probes into the marketing of its Depakote seizure med and the ongoing inroads made by the generic version of the Lipitor cholesterol pill, which boosted earnings reported by Ranbaxy Laboratories.

We should note that these drugmakers generated significant mention on Tweets, blogs, Facebook and other venues. But rather than simply list those that garnered the most attention – which would likely yield a few obvious candidates time and again – Semantelli chose those with the biggest change from the prior week.

An FDA advisory panel meets today to review a controversial move by Gilead Sciences to seek approval to market its Truvada HIV pill to prevent infection, which is also known as pre-exposure prophylaxis or PrEP. The move was both welcomed and criticized by AIDS activists, reflecting a spectrum of views on making a preventive pill available on a large-scale basis. To some, FDA approval would offer needed assistance in containing HIV and possibly clarify the extent to which such preventive measures are useful. To others, FDA approval raises the specter of creating a form of resistance to HIV due to widespread use, which would undermine effectiveness for existing Truvada patients and, therefore, diminish prevention efforts. In particular, critics worry people without HIV who take a preventive pill may engage in risky behavior. We spoke with Mitchell Warren, executive director at AVAC, about why the advocacy group supports PrEP…

Pharmalot: Why do you favor approval?
Warren: Taken together, all of the data begins to show us that if you take Truvada daily, you can get a substantial level of protection, up to 70 percent from HIV transmission. If you don’t take a pill you don’t get any benefit. What’s challenging is how do you help people who may be at risk adhere to the regimen? Those are programmatic issues that are really quite serious, but that’s not an aspect the FDA is likely to address.

Pharmalot: What data are you referring to? There seemed to have been contradictory results at one point.
Warren: As I look out over the last 18 month of results, there are different signals to digest. The first efficacy result was report in November 2010. There was a study of Truvada in men-on-men sex and showed 44 percent modest protection in six countries. Since then, there have been additional studies and they’re very complex results. On one hand, you can look at data and say it’s contradictory, but also say it’s beginning to tell a fairly consistent story. Another trial was stopped about a year ago after the DSMB (Data Safety Monitoring Board, at a schedule interim analysis, found there was no difference between the active and placebo arms, and recommended the trial be stopped… So if you look at those two trials, you could say it worked on men who have sex with men.

Then there was FemPrEP, which looked at just women taking PrEP in Africa and was stopped for futility. It was very confusing. But last July, at the International AIDS Society meeting, additional trial results were provided – a study in Botswana of heterosexual men and women (see here), and the Partners PrEP study, which was the largest and looked at Truvada and had people taking Viread alone. There were 5,000 couples and what was unique was about this was that one partner was HIV- infected and the other not infected. The HIV-negative partner was given Truvada, Viread or a placebo. The results showed both products – Truvada and Viread alone – were very effective in preventing transmission.

So across the studies there are different results, but more data was presented at a conference in March. The FemPrEP team presented additional analysis – 70 percent of women in the trial said they didn’t think they were at risk of HIV. And adherence data showed although there was very high self reporting of pill use, 30 percent of women had detectable drug. That means they weren’t taking the pill. And that’s why we saw no benefit in FemPrEP. The important comparison is the Partners study, where 80 percent had detectable drug. Partners showed Truvada provided 70 percent reduction in risk.

Pharmalot: What about the concern that some people may develop a form of resistance?
Warren: The most important part of PrEP, if approved, is to ensure there is testing on a frequent basis, probably on the order of every three or four months. We have to be sure before anyone takes PrEP they are HIV negative. The only cases of resistance in these studies came from people who initiated PrEP when they were already infected. We have to confirm HIV-negative status and have to be sure HIV monitoring is part of ongoing PrEP programs. Resistance is much more likely to develop and to be a concern in treatment than in prevention programs, because of the volumes. In prevention, people won’t get infected if they take the treatment effectively and won’t get HIV and so resistance wouldn’t develop.

Pharmalot: And why shouldn’t we be concerned about people thinking they can engage in risky behavior?
Warren: That certainly would negate the benefit. Most of that is about how we educate potential users of this product. This is partial protection. We see the same issues being raised around the world, such as in Africa where there’s discussion about male circumcision. People think it would provide added protection from HIV transmission. And people asked the same question – what about a subsequent increase in risky behavior? In male circumcision programs over the last five years, there’s no evidence of increased risk. It doesn’t mean it can’t or won’t happen, but there’s no evidence so far that it has. The issues need to b e very closely monitored in future programs.

Pharmalot: Still, people are people.
Warren: There needs to be an FDA requirement to Gilead about a REMS as part of any approval. We think the FDA should put requirements on Gilead to assure appropriate health educational materials are available for providers and users. So as a starting point, there has to be objective information about the use of mediation and prevention. This reality is going to be true of any prevention effort. If we don’t try to grapple with this issue programmatically to address the risk, knowing people are people, then we’ll never delivery anything in prevention or coming close to minimizing the impact of this epidemic. It’s one reason we’ve called for demonstration projects to learn how non-professionals can understand this and how we can counsel people.

And as part of approval, the FDA can insist on post-marketing surveillance and registers, which can’t be done when usage its off label. Others argue this would open the floodgates, but I think it’s absurd. PrEP is not going to be for everybody. It’ll be as a niche product. Some will use it for prevention some of the time, but not everybody will be able or want to take a pill every day for the rest of their lives for prevention. And no one is saying it should be rolled out for everybody to take the rest of their lives.

Pharmalot: And what about the cost? This is an expensive proposition that comes at a time when governments are strapped (read more here).
Warren: It’s a fascinating time. This exciting science is coming when we’re not doing so well economically. We’re hitting plateaus and this means we have to make some hard choices. In the US, Truvada is an expensive drug. It’s much less expensive in developing countries. The full list price in the US can be in excess of $10,000, but there are many programs that provide it much cheaper. Gilead provided a license for generic manufacturing in some countries, but it can still be expensive.

The question is whether PrEP can be cost effective? In certain scenarios, it can if it’s very well targeted at people who are at greatest risk and aren’t able to use condoms. There are mathematical models, but we don’t know yet programmatically how to do this. So whether the FDA approves or not, we need demonstration programs so we know what PrEP programs look like. As AIDS prevention, it’s not just a pill – it’s in the context of testing and counseling. Yes, cost is going to be a huge issue. But we shouldn’t ignore important logistical issues that paralyze us. Remember, 10 years ago, millions of people were not able to take these medications. There was no access and people said it wasn’t affordable. And now, these are being taken in developing countries and people are adhering to regimens, and the prices have come down. But I agree that cost may be the biggest challenge.

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 decision that bolsters the pharmaceutical industry, a federal appeals court has ruled that sales reps are not eligible for overtime pay. In doing so, the court also rejected the position taken by the US Department of Labor, which has filed briefs in numerous cases supporting the notion that sales reps are entitled to overtime. The ruling by the Seventh Circuit Court of Appeals combined cases involving reps who worked for Eli Lilly and Abbott Laboratories.

Whether sales reps are, in fact, entitled to overtime pay has been a closely watched and controversial topic. The debate has divided courts around the country for the past few years and the outcome has the potential to alter compensation for tens of thousands of industry employees who promote medicines. The US Supreme Court, in fact, is reviewing such a case and a decision is expected in late June (more on that later).

The key issue in the litigation has been whether sales reps are exempt from overtime provisions of the Fair Labor Standards Act. The FLSA overtime compensation requirement does not apply to employees who work as outside salespeople, but the law does require employers to pay overtime for hours worked beyond 40 hours a week, unless a FLSA exemption applies. And there are two exemptions.

One is the outside sales exemption: if an employee’s primary duty is to obtain orders or contracts (as defined by the statute) and regularly does so away from the employer’s place of business. Reps argue a direct sale doesn’t occur because drugs are actually purchased by patients and hospitals, which buy meds from wholesalers. They also insist they follow a script. Drugmakers argue reps are, indeed, outside salespeople who close sales because the primary customer is a physician.

There is also the administrative exemption, which relieves employers from paying overtime to any employee who is employed in a bona fide executive, administrative, or professional capacity – and to employees earning over $455 a week whose primary duty is to perform office or non-manual work involving managerial or general business matters. A primary duty includes exercising discretion and independent judgment.

The federal appeals court did not address the outside sales exemption, because the Supreme Court is reviewing that issue. That case involves two former GlaxoSmithKline reps, who were unable to convince a different federal appeals court – the Ninth Circuit – that they were entitled to overtime (see this and this). Last year, by the way, the Second Circuit ruled that Novartis reps are entitled to overtime (back story).

And so, the Seventh Circuit restricted its review in the case involving the former Lilly and Abbott reps to the administrative exemption. In reaching its decision, the court acknowledged that the physicians do not actually buy medications from reps, given that the pharmaceutical industry is tightly regulated. But the court did find that the administrative exemption applies.

“The representatives before us are the public face of their employer to the most important decisionmaker regarding use of their companies’ products, the prescribing physicians. The representatives neither produce the employers’ products nor generate specific sales, but service the production and sales aspects of the business by communicating the employers’ message to physicians.

“The goal of their work is to increase market share indirectly or, stated differently, to promote sales. To the maximum extent possible, their work is based on maintaining continuous and regular contact with the physicians to whom they are assigned, anticipating their objections and concerns and addressing them on behalf of their employers,” the court wrote (here is the decision).

In other words, reps are like bona fide administrators who promote product, and the court also ruled that they really do exercise discretion when deciding how to deal with physicians. In reaching this conclusion, the appeals court also declined to show deference to the Labor Department, which has argued in briefs in various cases that the courts should defer to its interpretation of applicable statutes and rules.

“To the extent that the plain language of the Department’s regulations are deemed ambiguous, controlling deference must be given to the department’s interpretation of its own regulations unless such interpretation is plainly erroneous or inconsistent with the regulations,” the Labor Department wrote in a brief filed in support of the former Lilly rep (you can read it here).

Where to from here? “If (the Supreme Court) rules that (sales reps) are outside sales exempt, (this decision) will have relatively small consequences for pharma industry,” says Richard Alfred, a labor and employment attorney who has represented various drugmakers in overtime lawsuits involving sales reps. “If (the court) rules that reps are not outside sales, then the 7th Circuit decision – joining the 3rd Circuit in finding the administrative exemption applicable to reps – will have major implications for the dozens of pharma cases pending and to be filed.”

In other words, if the Supreme Court rules in favor of Glaxo, the issue is over – reps will not be entitled to overtime because “all reps will be exempt everywhere,” says Eric Kingsley, one of the attorneys for the Lilly and Abbott reps. But if the Supreme Court decides in favor of the former Glaxo reps, then the debate over the administrative exemption will likely continue. He adds that an appeal of the 7th Circuit decision is being discussed.

Top of the morning to you. And a fine one it is. The sun is shining brightly and there are no clouds hovering over the Pharmalot corporate campus, where we are hustling those short people off to the local schoolhouses. Meanwhile, we are brewing that famous cup of stimulation and preparing for another busy day. And there is much to do. So here is that regular menu of tidbits to get you going. Hope you have a great day and let us know if you hear anything interesting…

Arena Is A Hot Stock As FDA Review Of Diet Pill Begins (Associated Press)

Cipla Breached Patent Rights By Cutting Nexavar Price: Bayer (Hindu Business Line)

FDA Panel Recommends Pfizer Rheumatoid Arthritis Pill (Bloomberg News)

FDA May Speed Approval Of Breakthrough Drugs (Reuters)

UK’s NICE Backs Roche’s Tarceva For Lung Cancer (Reuters)

As More Generics Loom, Pfizer Gives Up Lipitor Marketing (Wall Street Journal)

J&J Opens Doxil Rationing To New Patients (Dow Jones)

Glaxo: We Complied With Indian Rules For Drug Approval (Wall Street Journal)

Novartis To Probe Indial Drug Approval Allegations (Reuters)

Congress May Allow FSA Funds For OTC Meds Without An Rx (Amed News)

Lethal Injection Drug Held By Nebraska Is Recalled (Associated Press)

USDA Asks MRI To Rework Enclosures After Animal Death (Outsourcing Pharma)

J&J And Bayer Seek Expanded Use For Xarelto (Associated Press)

Pfizer Distribution Policy Criticized By Australian Wholesaler (Sydney Morning Herald)

EDITOR’S NOTE: Please check this post for updates

Next time you examine prescription drug information for a child, chances are that suitable safety or dosing data will be lacking. Why? A new study by FDA staffers found that only 231 medicines of 461 listed in the Physicians Desk Reference had adequate information that doctors would need to prescribe a drug to children. The study appears in the Journal of the American Medical Association (read the extract).

The findings are an improvement over a 1975 study that found only 22 percent of labeling was sufficient. And of new molecular entities approved between 1999 to 2009, those with pediatric labeling increased from 20 percent to 41 percent. Nonetheless, the authors say the lack of data is disturbing. “You can’t get a product approved in adults without studying how it affects them first,” Dianne Murphy, one of the authors, tells ABC News. “But children are routinely being given products that are not studied in them.”

The researchers analyzed labels of 560 different drugs used to treat a variety of ailments, everything from high blood pressure to allergies. They found 231 were properly labeled and 29 had useful info for some age groups. That meant 54 percent of labels lacked pediatric info. After excluding 100 drugs not deemed relevant to children, 44 percent of the drugs lacked sufficient labeling.

A contributing factor are hurdles to conducting pediatric studies and lack of evidence means doctors must extrapolate dosing information. “The number of children available with a disease is usually less, and there are very real challenges to doing research on therapy for children ethically,” Eric Lavonas, from the Rocky Mountain Poison and Drug Center, tells Reuters.

This means that proper labeling information is often lacking for diseases that are less common in children. “Kids are mostly healthy but they still get heart disease, they still get lung disease, they still get endocrine disease, they still get arthritis, they still get many of the diseases that adults get — and it’s in those populations that we can’t get things studied,” Murphy tells Reuters. The answer? The authors says there must be legislation to increase pediatric clinical trials and require that information is added to labeling.