FDA announced yesterday afternoon that the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) must bear black box warnings for serious mental health symptoms, including changes in behavior, hostility, depression, and attempted suicide.

In addition to being used in smoking cessation, buproprion is also marketed as an atypical antidepressant under the brand name Wellbutrin, as well as in a generic form. All these products will receive increased warnings highlighting the risks for mental health events. (The drugs already carry black box warnings for suicidality.)

According to FDA, symptoms have occurred in patients with and without histories of psychiatric illness, and tend to occur shortly after medication starts and end when treatment is stopped. But there have been instances reported where side effects continue even after the patient stops taking the drug. Read the rest of this entry »

A joint committee of three FDA advisory groups voted on Tuesday to recommend the elimination of prescription combination drugs containing acetaminophen due to a spike in instances of liver-induced toxicity.

The panel of experts, physicians, and regulators voted 20 to 17 in favor of banning acetaminophen combo drugs such as Vicodin and Percocet. They made it clear, however, that they are not calling for a ban on acetaminophen alone, or banning the narcotic component of the pain drugs—just those factors in tandem.

“The top recommendation of the committee is that the agency needs to do something to address and decrease the ‘usual dose’ of acetaminophen for OTC products and prescription combination products,” said Sharon Hertz, deputy director, Division of Anesthesia, Analgesia, and Rheumatology Products, CDER. “The usual dose that people take, whether it’s called the single dose or the maximum daily dose, should be lowered to ensure a greater margin of safety.” Read the rest of this entry »

FDA wanted to find out what people really think of the risk information printed on the back of pharmaceutical advertising. Surprise, people tend to absorb far less information from the giant blocks of text printed in drab language.

DDMAC social science analyst Amy O’Donoghue explained FDA’s recent study results to an audience of marketers at Drug Information Association’s annual meeting, yesterday.

“We recognize the current situation where pharma can just reproduce risk information written to doctors in print ads,” O’Donoghue said. So, we looked at current format and different ways of presenting the information and what format.”

The first study examined how people use the current brief information to determine if risk info and med condition affect the time people spend reading the ad, the comprehension of the info, the selection of topics, and the intention to ask a doctor.

FDA created a fake drug called Oncazil, which they used to treat asthma, high cholesterol, excess weight and produced low risk ad or high risk ads for each disease state. Read the rest of this entry »

At the Drug Information Association’s annual meeting, Pharm Exec got a few minutes to talk with a little software company named Microsoft’s about its work in creating integration between electronic data capture [EDC] and electronic health records [EHR], and its new Amalga technology.

Electronic Data Capture Integration
“I don’t think electronic data capture has evolved to where it should be yet - It’s not an adult yet,” said Microsoft life science strategist Les Jordon. “Companies say that they have a mature application, which is true, but we’ve got a lot of mature applications and everyone’s spin on EDC is slightly different. Where we see EDC going is really a merger of clinical trials management, which includes project management, electronic data capture, and integration with electronic medical records.”

Microsoft expects this merger of data sources will provide a seamless environment, so that pharma companies can find trial sites a lot easier and lower the expense of recruiting trial sites and maintaining them. Read the rest of this entry »

Neil de Crescenzo

Just a few days shy of the one year anniversary of the launch of Oracle’s Health Sciences Global Business Unit, Neil de Crescenzo, senior vice president and general manager for the business unit sat down with Pharm Exec to talk about the future of clinical trial software and technology and the need for standards and integration.

What’s the biggest challenge pharma companies are facing when it comes to their IT systems?
I think things are changing. Historically, pharma might have focused on one area where they were looking for new business functionality. Now, I think they’ve stepped back and asked, “How do I step back and get an end-to-end process that’s flexible to [provide different capabilities as my business changes], but also to serve as a platform to add new capabilities as we go forward?”

Companies are approaching us and other companies to find out how they can create a new way of approaching their business problems, where they can get many of them solved through the platform approach.

Where does cloud computing fit into the mix? It’s generating a lot of buzz, but is it the future?
I think the challenge of cloud computing is that they are really focusing on one element of how to deliver software and it’s often by companies who are trying to differentiate themselves by delivering that. You will find that the largest companies generally want options, because they would like different methods for delivering hosted software. Read the rest of this entry »

A panel of regulators from FDA’s Division of Drug Marketing, Advertising, and Communications were taken to task, this morning at the Drug Information Association’s annual meeting, for 14 warning letters levied on drug companies for not including risk information in online search ads.

A Sanofi Aventis employee complained about the 14 warning letters and asked why the practice of purchasing sponsored links on search engines, without fair balance information, was allowed to go on for so long if it was wrong and what else should companies be looking at that they might not know is wrong.

“If you do not know, of if you are not sure [if an ad is okay], submit a proposal for advisory comments,” said Kristin Davis, deputy director, DDMAC. “We have limited resources - the fact that you didn’t hear from us, just like the fact that you went 15 miles over the speed limit on your way to work - doesn’t mean that it’s okay. It just means that the cops weren’t on the road that day. Unless you have advisory comments indicating our opinion, you are not insulated from enforcement action. Especially if you are exploring some new tool and you are not exactly sure, I really encourage that you submit for advisory comments. We prefer that to sending out enforcement letters.” Read the rest of this entry »

The new commissioner of the Food and Drug Administration is mapping plans for turning around an agency that has been demoralized and buffeted about in the press, and has lost the trust of the American people. “Our mission is to protect the health of the people, using the best available science, in as transparent ways as possible, across all domains,” Margaret Hamburg told Pharm Exec in a media briefing last week that was part of her campaign to enhance communication about FDA policies and goals.

One lead initiative is to define FDA’s “global footprint” for dealing with food safety and drug and medical product development on an international basis. Establishing overseas offices is just one aspect of developing a comprehensive strategic approach to addressing global health issues, Hamburg explained. These hubs provide more on-the-ground understanding of local developments and will permit more “nimbleness” in a crisis, she pointed out. But FDA also needs to develop partnerships with sister regulatory agencies to promote harmonization and provide assistance and capacity-building in countries with less developed regulatory frameworks.

Tackling tobacco
A high priority for FDA is to develop a framework for regulating tobacco products. Hamburg feels strongly that FDA, as a science-based public health regulatory agency, is the appropriate organization to address the “important public health problems” raised by tobacco use. The agency is still developing staffing plans and the rollout for a new tobacco center, but Hamburg believes that the new legislation provides the necessary tools and authorities, and does not “overload the plate” at FDA. She does not expect to take resources from other areas to support tobacco regulation, or that broader organizational changes will be needed.

Despite the heightened focus on food safety and tobacco regulation, the drug and medical product area is crucial to FDA’s mission, Hamburg emphasized, adding that “I do not see us stepping away from that important component.” She regards industry as “absolutely key partners in what we do” and aims “to get more involved in issues of innovation and in providing swift reviews of new products.” This a good time, she feels, to take a new look at the Critical Path Initiative and at how FDA can leverage emerging science and technology to strengthen new product development and review, as well as postmarket surveillance and product communication.

In the marketing and promotion area, Hamburg said she “cares deeply about making sure consumers get access to appropriate and adequate information about the choices they need to make.” Yet she is concerned that in a world with such a wide array of media outlets such as blogs, Web sites, and 24-hour cable TV, “it is very easy for inaccurate information to get out there. We have a real responsibility to make sure that where we have authority and opportunity, we provide the clearest and most accessible public health message possible.” Hamburg wants to work more with drug companies and advertising firms to ensure that any information on medical products is accurate and reliable and reflects available scientific data.

Hamburg also anticipates a closer working relationship with the Centers for Medicare and Medicaid Services (CMS) to help move medical products “out of the review process and into the market place.” Early discussions can help CMS understand what new products will emerge, and which may enable them to streamline their own procedures for review and reimbursement, she explained.

The commissioner recognizes the importance of having the resources to attract and retain the expertise needed to accomplish these many goals. She hopes that her leadership will be marked by a “strong and clear emphasis on science-based decision making.” If there’s a question about the safety or efficacy of a drug on the market, though, “I will not have any hesitancy about examining it closely,” she warned.

Setting up a new tobacco center will take some juggling, Hamburg acknowledges, but it is a high priority. How FDA takes on these new responsibilities will be looked at as a measure of FDA’s leadership. “FDA needs to make significant strides in order to accomplish its mission in a global world,” said Hamburg

Senator Jennifer Beck

Pharma might be aTwitter about social media, but few companies are freeing their marketing teams to try new strategies to engage consumers and patients. And they have a good reason to be afraid. With FDA dropping warning letters for the most innocent infractions, there is legit trepidation in trying new online strategies.

So, it’s no surprise that social media was top of mind during the opening panel at today’s meeting of the Healthcare Communication & Marketing Association (HCMA).

After a slight rain delay due to the deluge of precipitation falling on North Jersey, Republican Senator Jennifer Beck took the podium to talk about some of the challenges facing the pharmaceutical and healthcare industry. Read the rest of this entry »

Ellen Hoenig Carlson of Advance MarketWoRx is live from Day 2 of the Games for Health Conference.

With the completion of the Games For Health Conference Friday, it was very exciting to see several innovative efforts in place. Despite being the early days in Health eGaming, momentum is quickly building behind games and virtual worlds as potential “game changers” to improve education, engagement, and behavior to positively influence health.

As we head into the “virtual” future of marketing, here are seven key implications for pharma to think about:

1. Adherence: An educational and behavioral change focused game can be part of a ‘meaningful’ compliance and persistence-marketing program. Too often the current adherence RM programs are simply a few reminders that are either Web or direct mail interventions. A well-designed adherence health game could provide significantly more engagement to not only remind patients, but also teach them how to use and incorporate treatment into their daily regimen. And could furthermore, help them understand why on-going behavior changes and adherence are needed to maximize success. Read the rest of this entry »

Guest Post:  AdvanceMarketWorx founder Ellen Hoenig Carlson live from the Games For Health Conference

This is the first of two blogs covering the fifth annual Games for Health Conference (clickable ink to www.gamesforhealth.org) in Boston June 11-12. You can also follow the conference on Twitter: #g4h09.

Almost 400 attendees, more than 50 sessions, and 100 presenters make up this year’s conference. “The Games For Health conference channels the creativity and vision of game and health professionals to improve health and health care for all Americans,” says Steve Down, assistant vice president of the Robert Wood Johnson Foundation, and the conference’s biggest sponsor.  “We’re seeing how games can effectively motivate people to adopt healthier behaviors, empower patients to manage chronic diseases better, and raise medical training and skill development to new levels.” Read the rest of this entry »