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The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!

Until next time...

Good Luck and Good Surfing!!!!!!!!!

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Mark Sendak, a social media enthusiast and author of the Eye on FDA blog, wrote a great post today about an article he saw in the Washington Post entitled “Drug Firms Jockey for Space Online.”

Mark wrote: “Flock?  Flock?  FLOCK?  The only way you could use the term "flock" in connection with pharmaceutical firms and social media is to say that companies are a scared flock of geese.” He goes on to castigate FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) for a lack of a coherent regulatory framework and guidance for the use of social media in the life sciences industry.

Mark aptly describes DDMAC’s guidance surrounding social media and the pharmaceutical industry this way. “No one knows, and DDMAC apparently makes this stuff up as they go along. That is the kind of Whack-a-Mole game DDMAC plays.  We won't tell you what is off limits, until you do it and then WHACK! Is this anyway to run a pharmaceutical industry?

I am in total agreement with Mark on this issue. Despite the rapid adoption of social media by other industries, FDA has consistently been reluctant to issue any regulatory guidance what so ever on the topic despite assertions to the contrary. Unfortunately, when it comes to social media and the pharmaceutical industry, FDA’s usual approach to regulatory guidance—reactive rather than proactive—is still alive and well. As you may recall FDA previously sent warning letters to no fewer than 14 pharmaceutical and biotechnology companies admonishing them on their placement of product ads on search engine results pages. The fact that 14 different companies received warning letters on this issue reflects the confusion and lack of guidance offered by FDA on social media and the use of Web 2.0 technologies to promote or support the sale pharmaceutical products.

The growing popularity and inevitability of social media suggests that DDMAC officials along with industry representatives must begin to consider crafting a preliminary regulatory framework for its use in the life sciences industry. Like it or not, social media is here to stay!

Hat tip to EyeonFDA!

Until next time....

Good Luck and Good Job Hunting

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Roche announced Tuesday that it will replace Arthur Levinson, PhD, Genentech’s current CEO and American biotechnology pioneer, with Pacal Soriot, DVM, MBA who currently leads Roche’s worldwide commercial operations.  Dr. Levinson will become Chairman of Genentech’s newly configured board of directors but no longer have control over day-to-day operations at the company.  Mr. Soriot will become CEO of Genentech and head all of Roche’s pharmaceutical activities in the US. Some of the other changes that will occur at the company include: Susan Desmond-Hellmann, Genentech’s president of product development, will move into an advisory role after the middle of this year. Genentech CFO David Ebersman is leaving the company and Ian Clark, who heads commercial operations for Genentech, will be chief marketing officer of Roche’s pharma division.

Dr. Levinson and Mr. Soriot will lead the efforts to combine all of Roche’s North American operations which ultimately will be run from Genentech’s South San Francisco location. Many of the activities at Roche’s previous North American headquarters in Nutley, NJ will move west, which means downsizing, more layoffs and possible closure of the Nutley site. 

Dr. Levinson, one of Genentech’s early employees, joined the company as a senior scientist in 1980 and has been its chief executive since 1995. During his tenure, Genentech became the largest, most profitable and perhaps the most innovative biotechnology company in the US. Unlike Dr. Levinson, who is a molecular biologist and has over 30 years of experience in developing successful protein-based drugs, Dr. Soriot, a former Sanofi-Aventis financial and commercial operations executive has little or no experience with biotechnology products.

With this in mind, I suspect that many things will change at Genentech as Roche attempts to transform the once heralded biotechnology company into a subsidiary of its pharmaceutical division. Don’t be surprised if you see a mass exodus from company. Farewell DNA, all good things must end!

Until next time...


Good Luck and Good Job Hunting (try Genentech, there will be openings soon)
 

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About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.

The Eye on FDA blog, which is very bullish on social media, has been keeping aof pharma companies that have created channels on YouTube, the video site owned by Google. To date, Sanofi Pasteur, GSK, Abbot and JNJ have taken the YouTube plunge (see SanofiPasteurTV , GSKVision, AbbottChannel, andJNJHealth).  I suspect that pharma companies are willing to take a risk on YouTube, because unlike other social media platforms, they can disable the functionality that allows viewer to leave comments, kudos or kvetches after viewing videos. This shields the companies from unwarranted claims, misinformation about its products and negative publicity.

At present, the US Food and Drug Administration, has issued little or no guidance on the use of social media by drug makers. This means that drug makers are in uncharted territory and can experiment with social media without fear of much regulatory oversight or scrutiny.  Now that pharma has broken the social media barrier, I wonder whether MySpace, Facebook and Twitter (the hottest new social media tool at the moment) will be next. Interestingly, I learned yesterday that Novartis uses twitter and can be followed @Novartis.

Off the record conversations with MySpace representatives suggest that a number of pharmaceuticals have quietly created branded product pages on MySpace for years.  As the MySpace rep put it, how can you ignore an audience of 60 million people?  Further, Facebook’s fan pages are growing in popularity and don’t be surprise to see pharma pages begin to appear there. It will be interesting to see how pharma will incorporate social media into its business and marketing models in the future.

Until next time…

Good Luck and Good Video Watching!!!!!!!!

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New Jersey-based Pharmacopeia, the first-ever combinatorial chemistry company, announced that it had agreed to be purchased by Ligand Pharmaceuticals in a stock deal worth about $70 million. Onetime a leader in combinatorial chemistry and high throughput screening, Pharmacopeia has struggled of late after it jettisoned its profitable molecular modeling division several years ago. While the company was able to advance several of its lead compounds into early phase clinical testing, its  longtime business model, predicated on multiple, small discovery deals with large pharmaceutical companies, was unable to provide enough capital to continue to sustain operations.

Pharmacopeia was established in 1993 after its founders licensed from Columbia University several of the first issued combinatorial chemistry patents. The company was a pioneer in combinatorial chemistry (and subsequently high throughput screening) and was the first to publicly tout the virtues of combinatorial chemistry in drug discovery. By the mid-1990s, many pharmaceutical companies had embraced combinatorial chemistry as the “next big thing” and began eliminating traditional natural product and medicinal chemistry jobs. The industry’s love affair with combinatorial chemistry grew so strong that many companies (most notably Merck), completely eliminated their natural products discovery departments in the late 1990s. Unfortunately, the role of combinatorial chemistry in drug discovery never lived up to its promised potential and was largely abandoned in the early 2000s. Although combinatorial chemistry is now part of the modern day drug discovery paradigm, this onetime “shining star” has largely been relegated to a minor supporting role.

I first became acquainted with Pharmacopeia in 1994 after I took a job with Transcell Technologies, a now-defunct biotechnology company that was co-located with Pharmacopeia in a research facility in Monmouth Junction, NJ. While Transcell and Pharmacopeia shared a cafeteria and some common laboratory equipment, Pharmacopeia employees were strictly forbidden to talk with Transcell employees— lest they inadvertently divulge proprietary combinatorial chemistry concepts that might jeopardize the company’s future. Coincidentally, a guy who lived two doors down from my family and me turned out to be Pharmacopeia’s in-house intellectual property attorney. Although, Ron and I became good friends, he was also extremely tight-lipped about the “goings-on” at Pharmacopeia. Privately-held Pharmacopeia went public in 1995 and at one time, its market capitalization was almost $1.0 billion.

By any reckoning, a 15-year run is outstanding for a biopharmaceutical company. However, as the old adage goes, “All good things must come to an end.” At present, it is not clear, whether or not California-based Ligand will relocate the company or cut jobs. Nevertheless, Pharmacopeia’s impending demise sends a clear signal that the golden age of combinatorial chemistry has ended!

Until next time….

Good Luck and Good Job Hunting!!!

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Merck announced last week that it will cut 1,200 sales jobs in the U.S. by the end of July. The company also confirmed a plan to eliminate a small natural products group in Spain and Rahway, NJ. Whereas the salespeople who lost their jobs were given notice by the company, the natural products researchers in Spain (and Rahway) learned of their imminent demise via a power point presentation given by a Merck executive (whose name has not been disclosed).

According to reports, the Merck executive inadvertently included a slide in his presentation that outlined the plan for the layoffs to an audience that included Merck employees. Oops… The decision to close down in-house natural products research will impact approximately 50 researchers in Spain and "a significantly smaller number" in Rahway, N.J., according to Merck spokesman.

Merck eliminated most of its natural products discovery programs about 10 years ago but apparently maintained a small group hoping for a natural products discovery comeback. I, along with others, think that the blockbuster drugs of the future will come from natural product discovery. For those doubters out there, would somebody care to tell me the names of any blockbuster drugs that were discovered by combinatorial and computational chemistry?

I rest my case! 

Thanks to Ed over at Pharmalot for the heads up on this story!!!!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!!

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Teva Pharmaceuticals announced  yesterday that it will invest €65 million in its facility in Waterford, Ireland, and that it is creating an additional 165 new jobs over five years. Teva has three pharmaceutical plants and a research and development facility on its Waterford campus which was previously owned by IVAX Corporation. The expansion has been helped by grants from Ireland’s inward investment promotion agency, IDA Ireland. 

The existing facility supplies Teva's European respiratory products and also makes a range of treatments for the US market. The site is also Teva’s main research centre for respiratory products. The investment is expected to double the production capacity of both its inhaler and tablet manufacturing capacity. Pharmaceutical Industries Ltd. acquired the respiratory products business as part of its acquisition of the IVAX Corporation in January 2006. 

This is good news for the Irish pharmaceutical manufacturing industry which has been experiencing something of a slow down over the past year or so.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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