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US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
4. Prioritize by first addressing the conditions that will most likely affect product quality.
5. Outline how and when each deficiency will be corrected.
6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
8. Keep in mind that there is a formal process available for you to dispute the findings.
9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time....

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)

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Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time...

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

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A new report released by Deloitte LLP entitled “To Friend or Not? New Insights about Social Networks in the Life Sciences Industry” indicates that roughly 65 percent of survey life sciences company professionals say their companies use or plan on using social networks in some capacity at a corporate level. Interestingly, 35 percent of those surveyed have no plans to do so!

Survey respondents say the lack of Food and Drug Administration (FDA) guidelines, consumer privacy concerns and a lack of a clearly demonstrated return on investment are the top three hurdles to widespread adoption of social networking platforms.

Even after the FDA guidelines for social networking are issued (who knows when that will be?), more than half (53 percent) of respondents still expect a significant amount of confusion around how life sciences companies can engage with social networks. Forty-six of companies that already use social networking tools will continue to use them but will not increase investment until the FDA provides guidance.

More than one-third of respondents (38 percent) are waiting for the FDA to issue guidance before making any investment. Nearly three in 10 respondents (28 percent) said their companies are waiting to see what ROI other companies get. However, the majority (73 percent) expect the budget allocated for social networking will increase over the next three years.

Additional findings from the report that surveyed marketing/brand management professionals include:

• Approximately 44 percent have an informal strategy for social networking that is not documented and/or fully supported by leadership, while 32 percent have no strategy at all.
• Survey respondents use social networking to disseminate information (51 percent), proactively seek information (42 percent), or to react or respond to pertinent information posted on an online social network (23 percent).
• One in five (20 percent) are indifferent to using social networking.

One of the authors of the study suggested that “Our survey findings demonstrate that the bulk of the use for social networking now is geared largely towards marketing. However, there are additional strategic applications beyond pure marketing still to evolve, such as conducting market research cheaper and faster; working with foundations to mobilize patients; improving peer-to-peer education through cost-effective medical education; determining the right patient reported outcomes; and providing data to help speed-up clinical trials.”

I have long contended that the least likely application of social media in the life sciences industry would be for promotional and marketing purposes. While this previously was a minority position, Jonathan Richmond, who authors the popular social media and marketing blog “Dose of Digital”, finally agreed with me in a recent post, entitled “Social Media is Not for Advertising Pharma Brands.”

Unfortunately, much of the early conversations surrounding the use of social media in the life sciences industry were promulgated by pharmaceutical marketing consultants and product brand managers. The early emphasis on promotional use caused many pharma executives to head for their command bunkers at the mere mention of social media (mainly because of its possible regulatory implications). Luckily, less financially-motivated persons began to join the conversation and successfully floated ideas about less regulatory risky uses of social media. Interestingly, the promotional use of social media in the life sciences industry is no longer the main topic of conversations at most pharma and social media conferences these days.

It appears that most life sciences companies are willing to concede that social media is not a fad and not going away anytime soon. As the old adage goes “You gotta be in it to win it.”

Until next time...

Good Lucking and Good Surfing!!!!!

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Whether you like President Obama or not, the changes he made in the leadership at the US Food and Drug Administration (FDA) is beginning to yield results. After just two years, the agency is well on its way to modernization and overcoming its descent into the dark ages during the failed Bush Administration.

Mark Senak, the intrepid author of the EyeonFDA blog has been assiduously following and blogging about many of the new things going on at the agency. First, in a post a last week, Mark noted that FDA has updated its website and created a product recall page that collects recall information on all of the products that it regulates and deposited it in an easy to find product recall page. With product recalls in the food and life sciences industry increasing in frequency, this page will help to alert consumers about tainted products before learning of them on the nightly news. 

Second, Mark points out that FDA has finally entered the 21^st century and is now fully engaged in social media.

“FDA begins to join the 21st Century launching a Facebook page that has been long anticipated on this blog. FDA has not completed the Social Media Quadrant - (1) a blog, (2) several twitter feeds (3) a YouTube channel, and (4) a Facebook page.  And as added good measure, the agency opened a Flickr page.  The agency is now fully engaged in activities that many in the industry it regulates think is forbidden them.... And the beat goes on.”

Finally, earlier this week FDA announced that it would hold long-awaited public hearings to get input on proposed biosimilar regulatory guidance. As Mark duly notes, this process is likely to be contentious and protracted.    

"The FDA has set November 2-3 for a meeting to get input on a wide span of questions regarding the development of a regulatory pathway for biosimilars.  The scope of the questions is demonstrative of the number of outstanding issues the agency faces and will likely result in a protracted process. "

Central to the debate (and ultimate success of biosimilars) is the question of interchangeability and substitution of name brand products with biosimilar molecules. According to Mark, the agency will focus on the following questions

"What factors should the agency consider in determining whether a proposed interchangeable biological product can be "expected to produce the same clinical result as the reference product in any given patient?"

"What factors should the agency consider in evaluating the potential risk related to alternating or switching between use of the proposed interchangeable biological product and the reference product or among interchangeable biological products?"

What has become patently obvious to many of us who have been following the debate over the last decade is that unless biosimilars are interchangeable or substitutable for brand name biologics, the commercial success of the biosimilar industry may be in serious jeopardy. Put simply, there is no question that safe and effective biosimilars can be manufactured; the real question is whether or not physicians will prescribe biosimilar products if they are required to be branded by regulatory agencies. This is because physicians are reluctant to switch patients to new biologic products if a patient is doing well on a currently prescribed regimen. Since most physicians pay little attention to drug pricing, it is highly unlikely that they will switch a patient to product simply because there may be a 20 percent reduction in drug price. And, unless biosimilar products are deemed interchangeable with their branded counterparts, pharmacists (based on insurance formularies) will not be able to offer patients a generic equivalent of a name brand biologics. 

With the cost of biologic treatments skyrocketing, it will be interesting to see what the agency will do with this question.

Until next time...

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

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Mark Senak, a pharmaceutical social media advocate and the author of the EyeonFDA blog, today reported that the Swiss pharmaceutical giant Roche published on its website a document entitled Social Media Principles. The document outlines Roche’s rules and regulations guiding the company’s use and commitment to social media.

In an accompanying statement, Roche officially affirmed the role of social media as part of its Communication Policy.

Roche actively uses Social Media to communicate with its stakeholders. As committed in our Communication Policy we want to be a transparent company and thus welcome this new form of communication.

Further, while the company recognizes the use and benefits of social media, it acknowledged the regulatory risks associated with the new medium

Roche recognizes the ubiquity and benefits of social media and welcomes its use - however, we also acknowledge that certain risks are associated with these new channels. We have therefore developed this guideline to help our employees use these new platforms in a responsible way.

Finally and perhaps most importantly, Roche appointed Sabine Kostevc as Head of
Corporate Internet and Social Media. 

Contact

Sabine Kostevc

Head of Corporate Internet and Social Media

• http://twitter.com/skoko
• global.social_media @roche.com
• Media Team

She may be the first communication executive to hold an official title that has the phrase ‘social media” associated it. Surprisingly, this may be the biggest development of all; mainly because once one pharmaceutical company does something new, they all similar to follow!

Roche’s willingness to publicly commit to the use of social media is a bold and calculated move by a company that recognizes its power and the major role it will likely play in the future of the pharmaceutical industry. Further, it suggests that Roche, unlike most of its competitors, it willing to take a proactive role in helping to shape the social media regulatory guidelines being developed by the US Food and Drug Administration. Finally, Roche executives realize that increased transparency and open communications with its stakeholder may help to improve the public image of big pharma companies and perhaps rekindle the innovation that has been sorely lacking in the industry.

The bottom line: Rather than remaining part of the problem, Roche has boldly proclaimed that it wants to be part of the solution!

Hat tip to Mark and Roche!

Until next time...

Good Luck and Good Tweeting err Facebooking err Blogging!!!!!!!!!!!

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There is a growing controversy over the rules governing whether internships offered by employers should be paid or unpaid. Many wage and hour regulators maintain that interns must be paid when their work is of “immediate advantage” to the employer. In this case, the interns should be considered employees and must be paid at least minimum wage. However, as the number of internships continues to rise, an increasing number of interns have complained of being placed in unpaid positions doing largely unskilled or menial work. Most labor experts agree that this provides an immediate financial advantage to an employer because the intern is doing unpaid work that is typically performed by a paid employee. 

Because of the growing popularity of internships, the federal government has established six criteria to determine whether or not internships can be unpaid. These include that the internship must resemble instruction or training given in a vocational skill or academic institution and that the intern does not displace or replace a paid employee and that the employer does not gain an immediate advantage from the intern’s work and activities. In other words, if an intern’s experience is mainly educational or beneficial to the intern the internship does not have to be a paid one. To confound the issue, the California labor department recently issued new guidelines on whether or not internships should be paid, with the new rules giving employers more latitude not to pay them

According to a recent article in the New York Times, the new rules stipulate that interns need not always be paid when they do some of the same work as company employees. The new guidelines suggest that interns could do occasional work done by regular employees as long as it “does not unreasonably replace or impede the education objective for the intern and effectively displace regular workers.” I suspect that other states will follow suit and redefine their criteria for unpaid internships.

Don’t be surprised if you see a spike in the number of unpaid internships offered for the summer of 2010 and beyond.

Until next time…

Good Luck and Good Job Hunting!!!

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Mark Senak, author of the incisive EyeonFDA blog and de facto watchdog of all things social media in the life sciences, has assiduously been tracking company and trade organization input to the docket for the Part 15 meeting on medical product promotion and the internet and social media. To date, according to Mark, the following companies and trade groups have officially submitted their comments and viewpoints to the docket                                                                                              

1. Covidien
2. Johnson & Johnson
3. Bayer Healthcare
4. Sanofi Aventis
5. AstraZeneca
6. Eli Lilly
7. Medtronic
8. Pfizer
9. Abbott
10. Novartis
11. Genentech
12. Sepracor
13. Merck
14. Medtronic
15. Biotechnology Industry Organization (BIO)
16. PhRMA
17. National Organization for Rare Disorders (NORD)

As you may recall, industry input was lacking and surprisingly absent from the public hearings held by FDA on the topic earlier this year. While news analysts and bloggers were incredulous that companies didn’t actively participate in the earlier public hearings, this behavior is typical of life sciences companies that like to do things quietly and, when possible, behind closed doors. Ironically, this lack of transparency and inclination to secrecy is the antithesis of social media. Is it any wonder then, that life sciences companies are suspicious and wary of the impact that social media may have on their ability to conduct business?

Until next time...

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

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Mark Senak, social media enthusiast and author of the EyeonFDA blog, raised the question on his blog today as to whether or not the US Food and Drug Administration (FDA) ought to have a fan page on Facebook: the ever expanding, ubiquitous social media platform. He aptly points out that FDA has already created a channel on YouTube and has a twitter account. So, why not a fan page on Facebook, he asked.

While Mark and I agree on most things, I am not convinced that having an FDA fan page on Facebook would make a difference in the way in which FDA communicates with the American public. FDA is already behind on the social media curve and, as the FDA public hearings held late last year suggest, the agency is struggling with formulating regulatory guidelines for its use by drug and devices manufacturers. Might not creating a FDA fan page on Facebook be the proverbial straw that broke the camel’s (agency) back? 

Perhaps I am overreacting to the whole Facebook phenomenon and grossly under estimating the agency’s capabilities. But I simply don’t get Facebook!  At best, it is overwhelming, difficult to navigate and seemingly cluttered mindless chatter and people engaging in Mafia wars. There is no question that a fan page would increase FDA’s exposure and its “hipness quotient” but to what end? The agency already has trouble maintaining and managing its existing web assets (have you ever tried finding information at FDA.gov?). Adding a new website would simply mean more work for overworked and underpaid government employee who seemingly play by different rules than the outside world.

Don’t get me wrong. I am an avid social media enthusiast who believes that persons who engage in social media must be “all in” to be effective. Having said that, I believe that the agency would be better served if it works to improve the navigability and accessibility to information on its existing web assets. There is no question that building an agency fan page on Facebook may convince Americans that FDA gets “the whole social media thing.” But if the fan page doesn’t provide Americans with relevant and useful scientific, medical and regulatory information, then adding a FDA fan page to Facebook will do little more than increasing the heft of an already bloated social media platform whose utility and effectiveness is already beginning to wane.

In my experience, building a website or fan page is the easy part; continuing to populate the pages and sites with useful, meaningful and temporally-relevant content is the difficult part!

Hat tip to Mark for starting the conversation!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Until today, direct-to-consumer advertising (DTC) has received very little attention during the recent spate of debates over healthcare reform. The NY Times reports that several members of Congress are introducing legislation that would curb the reach of DTC advertising. While reasons for introduction of new legislation vary—ranging from moral indignation over the mention of four hour erections during prime time to tax deductions for pharma companies that engage in DTC advertising—it appears that no stone will be unturned during the ongoing debate over US healthcare reform.

For those of you who may not know, DTC advertising is allowed in only two countries—New Zealand and the US. According to a Nielson Media Research report, in 2008 drug makers spent about $4.8 billion on DTC advertising for television, radio and print ads in magazines and newspapers. Not surprisingly, supporters of DTC point out that the amount of money spent by pharmaceutical and biotechnology companies on DTC advertising is negligible as percentage of total health care spending. Nevertheless, data convincingly show that DTC advertising can increase the number of prescriptions written for newly approved drugs. Of the $235 billion spent on prescription drugs last year, approximately $8 billion was attributed to DTC advertising.

Although some academic studies suggest that DTC advertising can help people who need to start taking drugs and others to remain compliant with existing treatment regimens, the lack of fair balance in many DTC ads that promote drug benefits and downplay risks is what is driving legislation to curb its use. The recent brouhahas over Pfizer’s Lipitor commercials, Bayer Pharmaceuticals’ ad that deceptively promoted its popular birth control drug Yaz and Merck and Schering Plough’s Vytorin ads that overstated the health benefits of the cholesterol lowering drug have convinced legislators that DTC must be fixed.

The US Food and Drug Administration (FDA) Division of Drug Advertising Marketing and Communications (DDMAC) oversees and has full responsibility for DTC advertising. However, it is important to note, that under current regulations, companies aren’t required to get approval from the agency before they appear. Sharing DTC ads with FDA is completely voluntary. However, if FDA receives enough complaints about particular ads, DDMAC will review them and notify the company if regulators believe that they contain information that is misleading, unbalanced or unsubstantiated. Companies that violate DDMAC policies and guidelines are typically required to show run all future DTC ads by FDA regulators before they can shown to the public.

Because of the small numbers of patients that are typically used during clinical evaluation of new drugs, it may take as long as five years before side effects and problems with certain drugs begin to emerge. With this in mind, DTC critics argue that there ought to be a five year waiting period or moratorium on DTC advertising after a drug is approved. Interestingly, about ten years ago, a friend who works for a major pharmaceutical company told me that she always waits five years before using a newly approved drug.  At the time, I thought it was an odd thing for her to say since she had been in the business for over 15 years. However over the past five years or so, several high profile drugs that were heavily promoted by DTC advertising had to be withdrawn from the market. To that end, while DTC advertising may be “great for business,” it may not always be in the best interest of American consumers who use prescription drugs!

Until next time...

Good Luck and Good Job Hunting

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The debate, if you can call it that, over whether or not interactive social media platforms like Facebook and Twitter can be used in the life science industry is moving forward at glacial speed. I decided that it was time to propose some ideas rather than continue to admonish the US Food and Drug Administration (FDA) for a lack of guidance.

There are several reasons which may explain the inertia surrounding the adoption of social media by pharmaceutical, biotechnology and medical devices and diagnostics companies. First, and perhaps foremost, FDA has been consistently reluctant to craft any useful guidance on the use of Web 2.0 technologies for research, clinical or promotional purposes. The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is still trying to figure out how to regulate website content. Is it any wonder that FDA is reluctant to tackle the regulatory implications and issues associated with social media platforms like Facebook and Twitter? Second, a majority of social media advocates— who are leading the charge at many life sciences companies—are marketing and advertising executives who tend to look at social media strictly as a promotional tool. Finally, much of what takes place at life sciences companies is proprietary and confidential—information flow between the company and its employees and the public is fastidiously monitored and tightly regulated. Because of this, the life sciences industry’s “process” is intentionally opaque—which is contrary to the goals of social media which is to promote transparency (or the illusion of it).

There is no doubt that the life sciences industry is the most highly regulated industry on the planet. While this represents a formidable challenge for adoption of social media, it is by no means insurmountable—especially if social media is used for purposes other than branding, marketing and advertising. For example, the most straight forward application of social media at life sciences companies would be in the areas of corporate recruitment and employee retention. Many Fortune 500 companies outside of the life sciences industry have been using Facebook, MySpace and LinkedIn for years for recruiting purposes. While not commonly acknowledged, life sciences companies have quietly begun to use Facebook, LinkedIn and MySpace to recruit prospective employees. Interestingly, the new kid on the block—Twitter—looks to potentially be a more powerful recruiting tool than any of its predecessors. Unfortunately, employee retention is no longer a priority at many companies. However, before the economic meltdown a number of companies, most notably Best Buy, were experimenting with social media to retain talented employees.

Another potential use of social media is for pharmacovigilance and adverse events reporting. Companies with approved products on the market are required by FDA (and other regulatory agencies that approved their products) to set up post marketing surveillance programs for adverse events reporting. By law, companies that receive adverse events reports from consumers, physicians or other entities must report them to the regulatory agencies that approved the product. Regulatory agencies maintain adverse events databases for all approved drugs and devices to monitor drug safety.  If designed and implemented correctly, interactive social media platforms like Facebook and Twitter (which operates in real-time) would make excellent pharmacovigilance and adverse reporting tools. Quite coincidentally, John Mack, who runs the Pharma Marketing Blog, reported a partnership between UCB and PatientsLikeMe.com to create a pharmacovigilance reporting platform for UCB products.

Recruiting patients for participation in clinical trials (to assess efficacy and safety of prospective new drugs) has become extremely challenging over the past few years.Traditional patient recruitment strategies include print, television and radio ads and in some instances, websites. All of these recruitment methods are costly, labor intensive and limited in their effectiveness because they only reach small number of prospective clinical trial participants. I contend that Facebook with over 200 million users, LinkedIn with members in over 140 different countries and Twitter which is growing rapidly would be ideal for clinical trial recruitment and retention purposes. Others have also proposed this idea.

Finally, while the use of social media to promote approved drugs and devices may be difficult because of regulatory constraints, it can be utilized to keep the public informed about prospective new medicines and promote a company’s image or brand. There is no question that the public perception of the pharmaceutical industry has been severely tarnished over the last few years.  The industry’s continued lack of transparency and failure to adequately disclose potential safety risks about some approved products continues perpetuate a negative image. One way to restore public trust and confidence is to use social media to actively engage the public in conversation on wellness, addressing unmet medical needs and prospective new medicines and treatments that are being developed. Also, social media platforms could be employed to showcase community outreach programs and discuss educational initiatives to improve science education and training.

Social media is no longer a new phenomenon or technology. It is a legitimate form of communication which has become an integral part of the Web 2.0 experience. I suspect that the life sciences industry will have to make a decision about social media in the not so distant future—or possibly miss a potentially game-changing business opportunity. And, as Ken Kesey aptly said in Tom Wolfe’s ‘The Electric Kool-Aid Acid Test’—“You’re either on the bus…or off the bus.”

 Until next time...

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

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The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have joined the ranks of Abbott, GSK, J&J and SanofiPasteur on YouTube. Pharmaceutical companies are taking advantage of the power of YouTube and other social media sites because regulatory guidance hasn’t been issued on its use to promote products or brand awareness. In other words, this is uncharted territory and companies can essentially 'test the waters' to see how far regulatory agencies will let them go.  I suspect that early life sciences company adopters of social media will garner substantial ROI before regulatory guidance is issued.

A lack of regulatory oversight, the ability to manage and control content and the low costs associated with creating Internet videos make YouTube and other social media sites attractive to pharmaceutical and biotechnology companies. The life sciences sector is just beginning to recognize the power of social media and the role that it may play in promoting products and brand awareness to consumers.  Expect many more life sciences companies to experiment with social media in the near future--its a veritable goldmine!

Until next time…

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

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The Bush administration spent the last eight years trying to weaken and dismantle the US Food and Drug Administration (FDA).  I thought the carnage at the agency would end in the waning days of one of America’s worst leaders. Sadly, I was mistaken.

As many of you may know, FDA regulations forbid drug companies from promoting off label use of previously approved drugs. Not surprisingly, drug companies were able to find loop holes in the regulations and off-label drug promotion reached unprecedented levels in the early 2000s. In response, the agency embarked on an aggressive, unrelenting campaign to combat off label drug promotion by drug manufacturers. This effectively changed the way in which pharmaceutical sales representatives interacted with physicians in the past few years. No longer would there be unsolicited gifts, lavish pizza lunches for office personnel or tickets to local sporting events. Neither the drug makers nor physicians were happy about the rule changes but the revised guidelines helped to lessen off label promotion of previously approved drugs. That said, it came as something of shock late last year, when FDA officials proposed a new set of guidelines that would ease the restrictions on off label drug promotion.

The new rules would allow drug makers to supply physicians with copies of published research reports describing off label uses of drugs that were previously approved for other therapeutic indication. As you might have guessed, the drug companies are ecstatic with the new guidelines. Who needs pens, mugs or pizza when you can simply hand a physician a reprint of article that show that off label use of an approved drug can treat potentially life threatening medical conditions.  What an ingenious way to boost sales of extant drugs for new indications without having to spend larges of money trying to win regulatory approval for them. While this would be a financial boon to the pharmaceutical industry, I don’t think it would be in the best interest of patients who may be prescribed a drug that hasn’t undergone the rigorous scrutiny of controlled, human clinical trials.

Many congressional democrats and drug industry critics opposed the guidelines when they were first proposed last year. But, like many other times over the past eight years, the Bush administration prevailed. Today, the agency announced (with little fanfare) that the new off label drug use guidelines would go into effect—one week before Barack Obama is inaugurated as President. 

Until next time…

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

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