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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 Senak, who writes the outstanding Eye on FDA blog, posted an interesting article today that tracks the number of warning letters issued by DDMAC (the center that oversees life sciences marketing and advertising) over the past 12 years. Not surprisingly, the number of warning letters issued by DDMAC fell precipitously during the Bush Administration, after reaching a high during the waning years of Bill Clinton’s presidency. In fact, the number of warning letters issued by DDMAC during the first two quarters of 2009 exceeds the yearly total of warning letters issued in the past 4 of five years. However, as Mark clearly points out, the 2009 year to date number of warning letters may be artificially inflated because of 14 identical ones issued on the same day (April 2) to 14 different companies regarding internet search engine advertising. Nevertheless, it is becoming increasingly apparent that the agency is beginning to emerge from a long slumber and that US regulatory oversight may be entering a new, more scrutinizing era. 

While increasing regulatory scrutiny may be appropriate after 8 years of no regulation at all, it is important that FDA doesn’t overreact and unnecessarily stifle new drug and product development. To that end, I believe that the agency needs to be reorganized, revamped and revitalized to replace its traditionally “reactive” way of doing business with a more “proactive” one.  For example, there is a burgeoning need for regulatory guidance on the use of social media by companies in the pharmaceutical, biotechnology and medical devices and diagnostics industries. Unfortunately, FDA has been unwilling or unable to enunciate a cogent regulatory strategy or any meaningful guidance on this topic. Consequently, many life sciences companies have refrained from using social media because they simply don’t know how to implement it in the current regulatory environment. I believe that FDA, not the companies it regulates, should take the lead on this issue.

Finally, it is becoming increasingly apparent that many companies will continue to refrain from using social media and other Web 2.0 tools until FDA crafts some useful guidance on these topics. Sadly, Web 3.0 is just around the corner and the agency is still struggling with regulatory guidance for corporate websites. Maybe Congress needs to craft some new FDA modernization legislation—it has been 12 years since the last modernization bill was passed!

Until next time....

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

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As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”

Communications between the public and government health officials is vital when trying to manage and control infectious disease outbreaks. “Every single government agency as well as companies and non-profits need to be digitally literate and competent in a time of pandemic” asserts Eye on FDA blogger Mark Senak. For their performances in recent infectious disease outbreaks, Mark gives CDC an “A” for effort—although there is substantial room for improvement. FDA on the other hand didn’t fair as well. “The FDA is not nearly as sophisticated in terms of digital. Their only Twitter account is for food recalls.  And their YouTube channels are all confusing and unorganized. They have a long way to go.”

The Internet was originally designed as a digital tool to transmit and move large amounts of information from one place to another. That said, it is also a powerful communication vehicle that can be used to broadcast valuable, scientifically-accurate information during infectious disease outbreaks by leveraging social media tools like Twitter, Facebook and instant messaging. To that end, it’s time for public health agencies to recognize the power of digital media and craft communication plans that can be implemented in the next infectious disease outbreak.

Until next time...

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

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Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 

Drug makers and other interest groups pay search engines like Google to place ads on search result pages after someone types in a related search word. The sidebar ads typically contain a eye-catching headline about a relevant medical condition or product and links to websites promoting certain products. The companies receiving warning letters included: Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forrest Laboratories, Genentech, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche, and Sanofi-Aventis. Not surprisingly, most of the world’s largest and most profitable were guilty of running misleading Internet search engine ads.

Historically, drug companies and FDA have engaged in a cat and mouse approach when it comes to advertising and marketing drug and medical devices and diagnostics. This is because FDA’s existing regulations that guide marketing and advertising practices are relatively lax and it provides drug makers with the opportunity to see how far they can push the agency before “they get caught.” While this practice may have been acceptable for print and television advertising, it may no longer be appropriate for Internet advertising— which potentially has a much broader and larger reach than traditional media because there are not national borders on the Web. Unfortunately, FDA has been slow (reluctant?) to react to digital media and is even more perplexed about social media and the drug industry. Rather than continue to play cat and mouse, I think it would be in the best interest of consumers if FDA and drug makers would sit down and craft new guidance on regulating Internet advertising and marketing practices. It is becoming increasingly apparent that the old rules are no longer sufficient as digital and social media continue to evolve.

Until next time....

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

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A panel of eight judges at the Wharton School of Business at the University of Pennsylvania was asked to identify the top 20 life-altering technologies that were developed over the last 30 years. The survey was sponsored by Knowledge@ Wharton, U Penn’s business publication and the PBS’s “Nightly Business Report.” 

Not surprisingly, the Internet was voted the top innovation followed by computers, mobile phones and e-mail. Interestingly, DNA sequencing and testing was listed as number 5—one of five technologies from the life sciences and medical sectors—the others being MRI, laparoscopy, genetically-modified plants, biofuels and anti-retroviral (HIV) drugs. Finally, Internet social networking, a recent innovation, made a surprise appearance on the list at number 20!. The entire list is as follows:

1. Internet, broadband, WWW (browser and html)
2. PC/laptop computers
3. Mobile phones
4. E-mail
5. DNA testing and sequencing/Human genome mapping
6. Magnetic Resonance Imaging (MRI)
7. Microprocessors
8. Fiber optics
9. Office software (spreadsheets, word processors)
10. Non-invasive laser/robotic surgery (laparoscopy)
11. Open source software and services (e.g., Linux, Wikipedia)
12. Light emitting diodes
13. Liquid crystal display (LCD)
14. GPS systems
15. Online shopping/ecommerce/auctions (e.g., eBay)
16. Media file compression (jpeg, mpeg, mp3)
17. Microfinance
18. Photovoltaic Solar Energy
19. Large scale wind turbines
20. Social networking via the Internet
21. Graphic user interface (GUI)
22. Digital photography/videography
23. RFID and applications (e.g., EZ Pass)
24. Genetically modified plants
25. Bio fuels
26. Bar codes and scanners
27. ATMs
28. Stents
29. SRAM flash memory
30. Anti retroviral treatment for AIDS

If your favorite technology wasn’t listed in the Top 30, please let me know and we can add it to the list!

Until next time...

Good Luck and Good Job Hunting (try social networks)!!!!!!!

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I vividly remember when Netscape and Microsoft were “duking it out” for browser dominance in the mid 1990s. As you may have guessed, I was an ardent Netscape supporter. Unfortunately, Microsoft cleaned Netscape’s clock and Internet Explore (IE) became the default web browser of choice for many years,

Although I run a blog, belong to many social networks and like to think of myself as somebody who readily embraces change, I have religiously used IE since Netscape’s demise. That said, I never noticed how slow and clunky IE was until I started working at home again. I always attributed IE’s slowness and frequently aberrant behavior at work to my employer’s woefully inadequate internet connection. However, because I connect to the internet at home via FIOS, IE’s continued lack of responsiveness and frequent crashes could no longer be explained by inadequate “pipe size” or poor connectivity.

The thing that sealed the deal for me were my unsuccessful attempts last evening to use IE to access my Fantasy Football League’s homepage to check yesterdays results. My obsessive need to learn my Fantasy Football fate, forced me to use Firefox to attempt to access the site (I downloaded a version of Firefox several years ago). While I still wasn’t able to connect to my Fantasy Football homepage (the servers were jammed by other obsessive people like me), I found that I was able to access many of my other favorite websites much more quickly and with greater ease than I had ever experienced with IE (with or without a FIOS connection). An apt comparison for the speed differences between Firefox and IE is Usain Bolt’s dominating performance over the rest of the field in the 100 meter race at this year’s Olympics in Beijing.

Over the past few years, many technologically-savvy people suggested that I switch from IE to Firefox. I didn’t because I subscribe to the notion that if “it ain’t broke, don’t fix it.” That said, I am now a Firefox devotee. I feel like I just emerged from the Dark Ages!!!!!

Until next time…

Good Luck and Good Web Surfing (use Firefox…it rocks)

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