On July 23, sanofi released a statement expressing concern about FDA’s decision to approve a generic version of Lovenox because of the “potential implications for patient safety.” Sanofi said the generic version, manufactured by Momenta Pharmaceuticals (Cambridge, MA) and Novartis’s generic-drug unit, Sandoz (Broomfield, CO), was not subject to the same extensive testing for safety and efficacy that Lovenox has undergone and therefore cannot be considered an equivalent drug. “By nature, Lovenox is a complex biological product and its efficacy and safety profile relies heavily on the strict adherence to the specific processes applied in its manufacturing as well as its traceability from the animal mucosa to the finished product,” according to the company statement.

FDA’s announcement of the drug’s approval acknowledges the challenges in producing the generic version and emphasizes that the appropriate precautions were taken before making its decision. “Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said Keith Webber, PhD, deputy director of the FDA’s Office of Pharmaceutical Science. 

Early this week, sanofi filed a lawsuit in the United States District Court for the District of Columbia seeking to overturn FDA’s approval of the generic Lovenox. Momenta Pharmaceuticals released an update on Tuesday that said sanofi’s suit sought a temporary restraining order and preliminary injunction forcing FDA to suspend and withdraw its approval of the abbreviated new drug application filed by Momenta and Sandoz. The court set a date for a hearing on Aug. 17, and in the meantime there are no restrictions on Momenta and Sandoz to market their generic version of enoxaparin sodium injection. The companies say they plan to “vigorously oppose” sanofi’s suit.

In other sanofi news, reports around the web, such as this one from the New York Times, speculate that sanofi is on the verge of making an unsolicited $18-billion bid for Genzyme. The bid represents an offer of roughly $70 per share of the Cambridge, Massachusetts-based biotech firm. Analysts are eagerly awaiting the release of a letter from sanofi detailing its offer for Genzyme. Rumors of the deal have been circulating for several weeks, as PharmTech editor Patricia Van Arnum described in her blog post from early July.

A recent Wall Street Journal article reported that in the last 10 months, 23 pharmaceutical and healthcare-related companies have gone public in mainland China and Hong Kong, according to data from Dealogic, a research and investment analytics firm. These deals collectively raised $5.37 billion although most of the deals were small: 17 deals raised less than $200 million and eight deals were for $100 million or less, but one deal stands out in particular. In September 2009, Sinopharm Group, China’s largest pharmaceutical company, raised $1.3 billion in an initial public offering (IPO) on the Hong Kong exchange.

To put that $5.37 billion in pharmaceutical and healthcare IPO funding into context, the US biotechnology sector raised only $547 million through IPOs in the first and second quarters of 2010 and $1.1 billion for all of 2009, giving the US biopharmaceutical sector only $1.7 billion in IPO funding during the past 18 months, according to data from Burrill and Company, a South San Francisco private merchant bank. When total financing into public companies (i.e., IPOs, follow-on public offerings, private investment in public equity, and debt) and funding into private companies (venture capital and other private funding) are taken into consideration, funding for the US biotechnology sector is substantially higher, increasing to $8.1 billion in the first two quarters of 2010 and to nearly $19 billion for all of 2009.

So what does this tell us? Although the aggregate size and financing into the US biopharmaceutical sector is certainly substantial, the sector should not take for granted investor interest in China’s domestic pharmaceutical companies. Why is this important? For the large Western pharmaceutical companies, a better financed Chinese domestic pharmaceutical sector poses competition, perhaps not directly for innovator drugs and higher-valued products, but for access to China’s market, particularly given the preference that would be given in China to domestic products and companies. Moreover, the emerging US-based biopharmaceutical sector also should take notice as China’s domestic bio/pharmaceutical players compete for the all-important IPO dollar and potentially other forms of financing.

According to recent data released by Sinopharm from the China Association of Pharmaceutical Commerce, eight China-based pharmaceutical companies had 2009 sales in excess of 10 billion yuan ($1.47 billion). Ranking these top companies in descending order are: Sinopharm, Shanghai Pharmaceutical Co. Ltd., Jointown Pharmaceutical Group Co., Ltd., Nanjing Pharmaceutical Co., Ltd., Guangzhou Pharmaceuticals Corporation, Anhui Worldbest Pharmaceutical Co., Ltd., Beijing Pharmaceutical Co., Ltd., and Chongqing Medicines Co., Ltd. Among the top 100 enterprises, 18 companies had sales revenues of more than 500 million yuan ($74 million).

With China’s pharmaceutical market valued at $76–$86 billion (based on 2008–2013 IMS Health estimates), the key question is how much of the market will be supplied domestically and to what extent will the projected 23–26% compounded annual growth rate (2008–2013) for China’s pharmaceutical market be an engine for growth for China’s domestic pharmaceutical companies.

The bottom line. Don’t discount the potential competition from China’s domestic bio/pharmaceutical companies.

A recent article in the New York Times cited a report by the outplacement firm Challenger, Gray and Christmas, which said that the pharmaceutical industry has cut approximately 34,987 jobs in the first half of 2010. The figures are based on the activity of US-headquartered companies and foreign companies with US operations and includes losses in the US and outside the US for those companies. The figure represented 12% of the 297,677 job losses in the first half of 2010, according to the report, giving the the pharmaceutical industry the dubious distinction of leading private-sector job losses thus far in 2010. Through the first half of 2010, the government/nonprofit sector ranked the highest among all industries with 98,776 job losses, followed by the nearly 35,000 job cuts in the pharmaceutical industry. The retail sector ranked third in job losses at 26,181, the computer sector fourth at 16,964 job losses, and then the telecommunications industry at 16,005 job cuts. In 2009, the pharmaceutical industry ranked third in job losses at 51,549, outpaced only by the retail sector, which cut 85,698 jobs, and the government/nonprofit sector, which reduced employment by 102,302 positions.

Unlike certain industries, such as retail, the computer, and telecommunications industries, which are closely tied to the cyclicality of the economy, the pharmaceutical industry, by providing a healthcare product, had traditionally been largely immune to macroeconomic vicissitudes. But it is those fundamentals that make the recent job statistics even more troubling. The losses reflect ongoing restructuring by Big Pharma companies following merger and acquisition activity or overall cost-reduction efforts as well as a constriction of the labor force among emerging pharmaceutical companies, many of which faced difficulty in securing financing in the recent economic downturn as well as in the inherent uncertainty in drug development.

So, unlike other sectors, where job growth may return with the gradual improvement of the economy as a whole, the pharmaceutical industry is in a transition as it faces increased generic-drug incursion in the innovator-drug sector, fewer new product introductions, and slowing market growth in the large and established markets in the United States and Western Europe. These trends are not new to anyone in the industry, particularly to those who may have been affected, but given the long lead times for product development inherent in the pharmaceutical industry, it doesn’t seem that job gains will be here anytime soon.

The suit was brought by Novartis employees whose primary responsibility is to visit physicians’ offices, drop off drug samples, and deliver scripted messages about the company’s products. Echoing the opinion of much of the pharmaceutical industry, Novartis argued that these workers are outside salespersons and therefore exempt from overtime pay under federal and state law.

The case finally reached the US Court of Appeals for the Second Circuit, which rejected Novartis’s reasoning. The decision might have been influenced by the US Department of Labor, which took the unusual step of filing an amicus appeal brief in support of the sales reps. This decision likely will affect the entire pharmaceutical industry, which faces several similar lawsuits filed by sales reps seeking overtime pay.

At first glance, the decision seems like good news for pharmaceutical sales reps. But the obligation to pay overtime might become another excuse for drug companies to cut their sales forces. In response to the recession, pharmaceutical manufacturers have laid off thousands of reps as a cost-cutting measure. Even without the recession, reps have been on shaky ground as physicians become increasingly unwilling to meet with them. As a result, companies have sought alternative ways of reaching doctors such as e-detailing.

I’m happy to see the Department of Labor and the Second Circuit protect sales reps’ right to fair compensation. On the other hand, I still fear for the reps’ jobs under the current market conditions. Maybe new blockbusters would be the best cure for these workers’ job insecurity.

When it comes to promotion of marketed products via Web 2.0 and social media, the pharmaceutical and device industries seem compelled (at least until regulatory guidance becomes public) to continue finding their way by trial and error. But the current state of affairs should not dissuade life sciences companies from engaging in one of the most promising and mutually beneficial online marketing activities: leveraging social media networks to drive clinical trial patient recruitment.

Many trial sponsors have questions about the value and legality of reaching potential participants online. Social networks have already demonstrated the ability to generate targeted numbers of pre-qualified patient referrals as well as lower sponsors’ overall cost per randomized patient. And whether recruitment happens online or through more traditional means, it doesn’t matter; clinical trial sponsors are neither selling a product nor making promises or claims about treatment. They are simply presenting trials as an option to potential participants. As long as we utilize sponsor- and IRB-approved content, the mechanism should not matter.

As in other enterprises, fortune will favor the bold in this venture into online clinical trial recruitment. Social networks—including MySpace and Facebook as well as increasingly popular sites such as bebo, Hi5, and Ning—have already proven that they have a place in the modern clinical trial recruitment mix. Sponsors who hesitate to utilize them are missing opportunities to proactively and cost-effectively place trial information directly in front of potential participants.

The Power of Networking

Social networking provides a tremendous opportunity for clinical trial sponsors. According to a February 2010 report from the Pew Research Center, 52 percent of adults ages 18–64 now have a profile on at least one social networking site. And since individuals have actively opt-in to social networking services, they are more likely to receive and act upon messages delivered through those media than they to respond to unsolicited communications or even traditional advertising.

Social networking sites also provide the potential for peer-to-peer influence and referrals. The viral aspects of social networking sites and related activities mean that a message’s reach can expand exponentially—without the accompanying exponential investment.

Let’s be clear though: Social networking is not a trial recruitment panacea. It’s highly unlikely that, by itself, a social networking campaign can fulfill the enrollment goal for any clinical study. However, assuming an understanding of the opportunities and limitations associated with social networking and e-recruitment, it can be a valuable part of the clinical trial marketing mix.

Define Audience, Identify Space

While the first foray into e-recruitment can be intimidating for clinical trial sponsors, social networking really isn’t so different from other methods of trial recruitment. Establishing visibility in an online environment requires the same basic approach utilized in more traditional recruitment channels: Define and understand the target patient group, then structure a strategy that will motivate them to respond.

Social networking sites are already designed to help sponsors target advertising and content based on the patient population, disease state, and research sites. Facebook and MySpace, for example, have the ability to target advertisements to individual users’ pages based on information in user profiles, including gender, birth date, and geographic location.

Given the fact that social networks reach people in nearly every major city in every country on the globe, the ability to target messaging geographically (geo-targeting) is critical, helping ensure the cost- and recruitment-effectiveness of online trial promotion. Both Facebook and MySpace allow advertisers to target messaging within a specific radius of a city or by ZIP code. It’s best to stay within 30 miles of the site for most disease categories, as distance to a research site is still, by far, the number one factor in patients’ choice to participate in a trial. Trials recruiting for serious indications such as cancer are the exception to this rule. These patients are willing to travel farther for treatment, so sponsors can usually extend the geographic recruitment radius.

Next, develop approved messaging for use in various formats. It’s important to develop a full range of discrete messages in the form of online advertisements, canned tweet responses, and text-based hyperlinks. These are the most common formats that social and online health networks use throughout their distribution channels, and sponsors need regulatory approvals for all of them.

But the approval process doesn’t stop there. Once a sponsor submits an IRB-approved message or advertisement for inclusion on Facebook or MySpace, an internal editorial committee at the respective social networking service reviews the content. If it’s approved by this committee, the ad is displayed within specific sizing and placement parameters on the network. Edits to content must go back through the regulatory, sponsor, and social networking approval loop, but the online nature of the messaging makes this process much faster than editing and re-approving advertisements for traditional media like television.

Disseminate Content in Selected Spaces

Once the target patient is defined and content and messaging are approved, sponsors are ready to begin strategically and systematically introducing the content into selected social networking spaces.

While the list of social networking services with critical mass behind them is always growing, sponsors also have the option to create their own unique, specific applications that run on users’ social networking “desktops” (Facebook or MySpace profiles). Advertisers build these applications using publicly available application programming interfaces (APIs) developed and published by respective social networks. APIs enable individual applications to function and behave consistently in terms of installation and dissemination within given networks, including how users share an application with network friends.

Last year, Acurian created and launched “Click It Forward” (CIF), a proprietary initiative and application designed to grow clinical trial awareness online, increase patient access to relevant trials, and increase sponsors’ access to interested participants. The initiative invites Facebook and MySpace users to add CIF, a cause-related social marketing application, to their profile pages, in exchange for a donation to a selected health-related cause. Based on the cause or causes that each user selects, Acurian displays specific clinical trial participation opportunities on the CIF dashboard and sends IRB-approved e-mails to users who have provided permission to be contacted.

Monitor Results, Adjust Resources

The on-time, on-budget completion of any clinical trial recruitment effort is always dependent upon the ability to measure, assess, and adjust recruitment tactics in real time. This capability has become even more critical in the current environment, as recruitment budgets shrink and the marketing mix becomes more complex. Sponsors need tracking mechanisms that allow them to immediately identify less effective tactics, and redirect time and money into those that are generating a better return—whether online or not.

The availability of channel-appropriate, effective options should apply to pricing as well. Traditional online promotional pricing is based on cost-per-click or cost-per-thousand impressions. These pricing systems do not protect sponsors from curiosity seekers or geographically inappropriate users who click on trial ads (therefore incurring cost) while never intending to participate in studies. Without a performance-based pricing structure in place, sponsors bear the risk of online advertising that is too broadly disseminated or that attracts too many virtual “tire kickers.” Sponsors should look for recruitment partners with the business volume to negotiate payment based on achieving a meaningful recruitment milestone, such as pre-qualified patient referrals that are geographically proximate to a participating research site.

Equally important is the ability to track and measure all sources of e-recruitment in real time. Performance can vary greatly within social networks, and it is imperative that clinical trial teams have the ability to act quickly when managing a recruitment budget. Most major recruitment firms offer platforms that collect and evaluate conversion ratios from dozens of Internet-based sources simultaneously and in real time, and then integrate these data with the results from more traditional recruitment activities. These dashboards enable study teams to evaluate and adjust their strategy in the heat of battle to further ensure that recruitment funds are allocated to top performing campaigns and research sites.

In the face of continued uncertainty around online patient and consumer communications, many clinical trial sponsors have adopted a “wait and see” approach toward e-recruitment. Fortunately, though, there is already enough accumulated e-recruitment experience that sponsors can be assured of its viability. Waiting to venture out into this new world could mean sacrificing time, dollars, and potential participants. In 2009, a full 54 percent of all pre-qualified patient referrals generated by Acurian’s recruitment efforts came from online initiatives. And, as individuals increasingly get their news and information online, traditional recruitment channels will continue to fall behind in terms of prominence and value.

With the right approach, the right experience, and the right tools, social networking channels can be cost-effective and efficient recruitment tools that put sponsors’ messages in front of selected, active and engaged audiences.

Scott Connor is VP of Marketing at Acurian.

The Bloomberg report indicated that sanofi aventis is in the early stages of considering an acquisition of roughly $20 billion or so. The speculated targets of Allergan, Biogen Idec, or Genzyme have product portfolios that are aligned with industry projections of strong growth, namely for specialty drugs and biopharmaceuticals. The market for specialty pharmaceuticals, defined as a class of medications used to treat complex, chronic conditions, comprised 21% of the US market by value in 2009 and increased 7.5% in 2009, according to IMS Health. IMS projects annual growth of more than 10% through 2014 for drugs to treat oncology, diabetes, multiple sclerosis, and HIV. Industry estimates place biopharmaceutical growth in the double digits. This growth compares with near-term estimates of only a 4–7% gain for the global prescription drug market as a whole, according to IMS.

Allergan, a specialty pharmaceutical company that makes eye-care treatments and Botox, had 2009 sales of $4.5 billion, of which $3.6 billion were in specialty pharmaceuticals. Sales of its specialty pharmaceutical sales increased 5.1% in 2009 compared with 2008. Biogen Idec, which announced the appointment of a new CEO this week, is dependent on three major drugs: two drugs to treat multiple sclerosis, Avonex (2009 sales of $2.3 billion) and Tysabri (2009 sales of $776 million), and Rituxan, used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis, and which netted Biogen Idec 2009 sales of $1.1 billion as part of a codevelopment deal with Roche. Genzyme reported 2009 revenues of $4.5 billion, but has experienced recent manufacturing and revenue problems for some of its key products. The company reported first-quarter 2010 revenue of $1.07 billion compared with $1.15 billion in the same period in 2009, reflecting limited shipments of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta) due to product-supply constraints. The company’s first-quarter net loss (based on generally accepted accounting principles) was $114.9 million compared with net income of $195.5 million in the first quarter of 2009.

If sanofi-aventis decides to purse one of these companies or another company, it will join the list of pharmaceutical companies trying to increase revenues through acquisitions. Although not at the scale of the mega-mergers in 2009 (Pfizer-Wyeth, Merck-Schering-Plough, and Roche-Genentech), an acquisition of $20-billion or so would be greater than another recent mid-sized acquisition: that of Solvay Pharmaceuticals by Abbott for EUR 4.5 billion ($6.2 billion), a deal that was completed earlier this year.

A recent analysis by Datamonitor shows how crucial acquisitions have been and will continue to be to Big Pharma as it struggles to increase revenues through organic growth, which has been hurt by fewer and lower-valued new product introductions and increased generic-drug competition. In 1995, sales from Big Pharma were $84 billion, and based on organic growth only, would be forecast to increase to $195 billion by 2014 (an absolute increase of $111 billion). However, the contribution of merger and acquisition (M&A) activity is forecast to lift 2014 sales to $381 billion, augmenting sales by an additional $186 billion. Thus, as a proportion of absolute growth over the period 1995–2014, M&A activity is forecast to account for approximately 63% of revenue growth for Big Pharma companies.

So the conjecture that another Big Pharma company is evaluating its options for another deal is not surprising. But it will be interesting to see what the next marriage in Big Pharma M&A will be.

How did we get here? The 2010 report shows that compared with last year’s data, the country’s obesity epidemic is growing steadily. The report’s summary also points out that in 1991, no state had an obesity rate above 20%.

“Obesity is one of the biggest public health challenges the country has ever faced, and troubling disparities exist based on race, ethnicity, region, and income,” said Jeffrey Levi, executive director of TFAH. “This report shows that the country has taken bold steps to address the obesity crisis in recent years, but the nation’s response has yet to fully match the magnitude of the problem. Millions of Americans still face barriers—like the high cost of healthy foods and lack of access to safe places to be physically active—that make healthy choices challenging.”

Some examples of the racial, ethnic, regional, and income disparities Levi mentions are given in the report’s findings:

• Adult obesity rates for Blacks and Latinos were higher than for Whites in at least 40 states and the District of Columbia
• Ten out of the 11 states with the highest rates of obesity were in the South
• Thirty-five percent of adults earning less than $15,000 per year were obese compared with 24.5% of adults earning $50,000 or more per year
•  The number of states where adult obesity rates exceed 30% doubled in the past year, from four to eight.

Perhaps the most troublesome is the data on childhood obesity. The results show that:

•  Childhood obesity rates ranged from 9.6% (Oregon) to a high of 21.9% (Mississippi)
• Eight states, plus the District of Columbia, have childhood obesity rates greater than 20%
• Nine of the 10 states with the highest rates of obese children are in the South, as are nine out of the 10 states with the highest rates of poverty.

A poll on childhood obesity was included in this year’s report. Eighty-four percent of parents said their children are at a healthy weight, however, research shows that one-third of children are overweight or obese, according to the report. This finding suggests that parents do not think of their own children as having a weight problem. Additionally, the poll results showed that 80% percent of Americans identified childhood obesity as a growing problem, and 50% of Americans believe the issue is so important that we need to invest more to prevent it immediately.

In February of this year, Michelle Obama launched the “Let’s Move” program, an ambitious campaign seeking to end childhood obesity within a generation. The program’s goal is “that children born today will reach adulthood at a healthy weight.” Public and private organizations have already started working toward that goal by taking steps to help parents make healthy, informed choices; serve healthier food in schools; help people access healthy, affordable food; increase the number of farmer’s markets; and encourage more physical activity. At the same time as the Let’s Move launch, President Obama announced the formation of a task force on childhood obesity that would identify ways to maximize resources and set benchmarks to achieve the Let’s Move goal.

Following the announcement of the “Let’s Move” campaign, FDA Commissioner Margaret Hamburg wrote an open letter to industry in March calling for better nutrition labeling on food packaging to help consumers make healthier choices. Hamburg focused on the food industry’s use of what could be misleading information to consumers and urged companies to make sure their labeling did not contain unauthorized health or nutrition claims.

And, of course, there are pharmaceutical treatments on the market and in development to fight obesity. Just yesterday, Eisai announced it made a deal with Arena Pharmaceuticals to commercialize the drug candidate lorcaserin, which is designed to control appetite and satiety. Eisai will pay Arena $50 million upfront, up to $90 million in milestone payments, and roughly 30% of product sales. With FDA approval, Eisai will sell the drug in the US. The companies expect an answer from FDA by October of this year.

It is promising that with these measures we can begin to overcome the many complex causes and factors related to the obesity epidemic—physical, emotional, social, ethnic, economic—that we deal with as individuals and as a nation. I sincerely hope that in years to come we can celebrate our country’s 250th 4th of July as a slimmer, healthier America.

The HHS report noted that 80% of approved marketing applications for drugs and biologics contained data from foreign clinical trials. More than half of clinical-trial subjects and sites were located outside the United States. Western Europe accounted for most foreign clinical-trial subjects and sites. Central and South America had the highest average number of subjects per site. Overall, FDA inspected clinical investigators at only 1.2% of all clinical-trial sites for applications approved in fiscal year 2008. It inspected 1.9% of domestic clinical-trial sites and 0.7% of foreign clinical-trial sites. The report said that challenges to conducting foreign inspections and data limitations inhibit FDA’s ability to monitor clinical trials, which included problems of having early-phase clinical trials being conducted outside the US without investigational new drug (IND) applications.

In its report, HHS recommends that FDA require standardized electronic clinical-trial data, monitor trends in foreign clinical trials not conducted by INDs, and to continue to explore ways to expand its oversight of foreign clinical trials. Such recommendations are reasonable, but they also raise larger policy questions that come into play with the increased globalization of the pharmaceutical industry. That is, given the nature of the products being made and the attendant regulation that is required, should a different model of business practices and regulation apply to pharmaceutical products compared with consumer and industrial products? Should another set of rules of apply?

There is no easy answer to that question as it requires a balance of free-market principles with public regulation. Drug products, unlike consumer and industrial products, require a higher level of regulatory oversight to ensure their safety and quality. Products developed or manufactured outside the US are neither implicitly better or worse than products developed or manufactured in the US. But given the limitations of financial resources and jurisdictional authority of US federal agencies outside the US, is it a prudent course to have clinical development or manufacturing of pharmaceutical products that are targeted for the US market, to be performed outside the US? Is this question an economic debate of free trade versus protectionism or a broader policy matter in ascertaining the relevance of domestic regulation in a global marketplace? Should regulation dictate business practice or business practice dictate regulation?

It seems now that we have a hybrid response. During the past several years, FDA has responded with the opening of offices in China, India, Central America, and South America as a way to increase its oversight of pharmaceutical development and manufacturing outside the US, which is a good move in the interest of public safety. But again, it raises another broader philosophical question: should federal resources be used to indirectly support offshoring functions outside the US? There is an ongoing policy debate as to how to increase the US position in science, technology, engineering, and mathematics (STEM) with initiatives supporting STEM activities in education and suggestions to foster competitiveness in innovation. But in the case of pharmaceutical products, is there a disconnect in federal policy, where on one hand we want to encourage STEM activities domestically, but on another hand are indirectly fostering STEM activities outside the US?

A lot to consider. Admittedly, it is a difficult balance of short-term, long-term, economic, and scientific goals, but perhaps one in which the sum of the parts rather than the individual parts should be considered.

“…We have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth,” said Hamburg and Collins. “Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time. We recognize that myriad obstacles must be overcome to achieve these goals.”

To that end, Hamburg and Collins said in their commentary that the NIH and FDA will invest in advancing translational and regulatory science, better define regulatory pathways for coordinated approval of codeveloped diagnostics and therapeutics, develop risk-based approaches in reviewing diagnostics to assess their validity and clinical value, and make information about those tests more readily available.

They cited data that showed that only about 10% of labels for FDA-approved drugs contain pharmacogenomic information, underscoring the deficiencies in information for advancing personalized medicine “There has been an explosion in the number of validated markers but relatively little independent analysis of the validity of the test used to identify them in biologic specimens,” they said.

To fill this information void, NIH, with advice from FDA, other Department of Health and Human Services agencies, and other stakeholders, is creating a voluntary genetic testing registry as a single public source of information on the more than 2000 genetic tests that are available through clinical laboratories. The registry will include information such as whether a test has been approved by FDA and data on genetic variants.

NIH and FDA also pointed to other efforts, such as a recent NIH-FDA collaboration on regulatory and translational science, announced in February 2010, which includes joint funding for regulatory sciences. They also pointed to NIH-supported research centers, the NIH Therapeutics for Rare and Neglected Diseases Program, the NIH Clinical and Translational Sciences Award Program, FDA’s efforts under its Critical Path Initiative to improve evaluation tools such as biomarkers and assays, and FDA’s Voluntary Genomic Data Submission Program (a forum under which companies can discuss genomic information with FDA separate from the product-review process) as ways in which policymakers are facilitating the advancement of personalized medicine.

Such collaboration is important, but the key question going forward is whether it will be enough to advance a promising but still unknown field. In their concluding comments, Collins and Hamburg likened the government’s efforts to building “a national highway system for personalized medicine.” Let’s hope that we are going down the right road.