Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

Given the current state of the economy and the fact that pharmaceutical sales have been crunched over the past several years, job cuts are not surprising. The US unemployment rate has gone up a full percentage point in the past year, from 4.5% in May 2007 to 5.5% in May 2008; the rate in New Jersey went up from 4.3% to 5.0%. Below is a look at some of the largest cuts that pharmaceutical companies—nearly half of them based in New Jersey—have announced since early 2007.

(Raymond Medici/Getty Images, Cartesia/Getty Images)

Articles

Staff reductions are not surprising with the state of the economy and falling pharmaceutical sales.

Trends: Industry Job Cuts

We recently added a callout to the end of our peer-reviewed articles, but we're not sure you've seen it. The red icon asks for your input on the published paper: What would you have done differently if it had been your experiment, your process, or your equipment? We, and the authors of the research papers herein, would like your feedback. 

We welcome you to email your thoughts to us at 

 regarding any peer-reviewed papers, or any articles for that matter, that appear in the magazine or on our website and we'll post your comments in a special online section at the end of the appropriate article. Our goal is to encourage more discussion among industry peers to promote the exchange of ideas and ultimately, innovation.  

In fact, we just launched a call for nominations for the 2008 Innovations in Pharma Science Awards, which will honor achievements in the pharmaceutical sciences. Check out 

 to nominate your company's work in one of five areas: drug delivery, formulation, dosage forms, pharmaceutical analysis, and API synthesis. The winners will be announced in the December issue. 

, where you can exchange ideas with the editors and experts by commenting on current posts, or adding your own post. What better way is there to increase your industry knowledge and advance your on-the-job skills than to talk to those people doing the same thing you're doing? So join us online and let's get talking.  

Forums, blogs, and more can spark innovation.

Talked to Your Peers Lately?

Emerging markets, particularly the "BRIC" countries (Brazil, Russia, India, and China), are playing an increasingly important role in pharmaceutical industry growth. Although these markets still account for only a relatively small portion of the global pharmaceutical market, recent and projected growth is strong.  

The BRIC countries, along with Indonesia, Mexico, and Turkey, are expected to account for as much as one-fifth of global pharmaceutical sales by 2020, according to a recent PricewaterhouseCoopers (PwC) report (1). In 2004, these markets accounted for only 8% of the global pharmaceutical market. The established markets of the G7 countries (Canada, France, Germany, Italy, Japan, the United Kingdom, and United States) accounted for 79% of the global sales  market in 2004, according to PwC. 

IMS Health defines what it terms the "pharmerging markets" as the BRIC countries, Mexico, South Korea, and Turkey. By 2011, these pharmerging markets are expected to contribute about 27% to overall global pharmaceutical growth and hold 16% of the market, compared with a projected 38% market share held by the US, according to IMS.  

The BRIC nations' pharmaceutical sales grew significantly between 2006 and 2007 (see Table I), according to IMS. Brazil's sales went up nearly 10% to $15.7 billion. China's pharmaceutical sales grew over 25% to $17.6 billion. India's sales went up 13% to $9.2 billion. Russia's sales grew by approximately 20% to $7.9 billion. By 2011, IMS projects that China will step out of its current "emerging" classification and move into fifth place in the global pharmaceutical market with the UK in the number six position. The largest pharma markets in 2011 will be, in order: the US, Japan, France, Germany, China, and the UK, according to IMS.  

Table I: Pharmaceutical sales among the BRIC countries  

The 2007 growth rates were well above the growth rates of the global and US markets. In 2007, US pharmaceutical prescription sales increased 3.8% to $286.5 billion, and global pharmaceutical prescription sales increased 6.4% to $711.8 billion in 2007.  

Although the growth rates of the market leaders are much slower than those of the emerging markets, the value of the leading markets is hardly comparable to that of the BRIC countries. Product mix and the corresponding value of these products are important considerations. The top therapeutic categories in the US are antidepressants, lipid regulators, codeine and combination pain medications, angiotension-converting enzymes inhibitors, and beta blockers, according to IMS. The top five products in 13 key global markets (Argentina, Australia, Brazil, Canada, France, Germany, Italy, Japan, Mexico, New Zealand, Spain, UK, and the US) between March 2007 and March 2008, were "Lipitor" (atorvastatin calcium), "Nexium" (esomeprazole magnesium), "Plavix" (clopidogrel bisulfate), "Seretide/Advair" (fluticasone propionate; salmeterol xinafoate), and "Enbrel" (etanercept). These same 13 countries had retail pharmacy sales (including prescription and certain over-the-counter sales) of $424.9 billion between March 2007 and March 2008, according to IMS. In contrast, top product sales among the BRIC countries include several more basic or commoditized products, including antibiotics, over-the-counter (OTC) pain and cough medications, and herbal or traditional remedies, although in certain countries such as Brazil, lifestyle drugs make the top product listing (see Table II). 

"You almost have to look at each country differently to understand its environment," says Diana Conmy, corporate director of IMS Market Insights Conmy. "In China, for example, you have a lot of traditional Chinese medicine that skews their top 10 product list. In the other BRIC countries, there are large OTC markets because their healthcare systems are not as well developed, and people are used to self-medicating. In Brazil, there are lots of generic products and what we consider lifestyle products such as Viagra that show up in the top 10. Each environment is unique." 

As the economies of the emerging markets improve, the nature of their pharmaceutical demand will change. "As GDPs increase and quality of life gets better, they begin to acquire more chronic diseases, and typically more Western diseases," says Conmy. "So you see a higher prevalence of obesity, which leads to a higher prevalence of diabetes. And as people live longer, there are more incidences of cancer, heart disease, and so on. Essentially, as countries develop, their disease profiles change over time. That provides opportunity for drugmakers." 

Table II: Top pharmaceutical products* in BRIC countries 

Aging populations also provide a potential consumer base, but these and other opportunities have to be weighed against access in these countries.  "As we've seen in the US, Japan, and Europe, the transition of the aging is beneficial to chronic conditions such as heart disease, high blood pressure, diabetes, etc., which are more prevalent in the elderly," says Conmy. "But at the same time, it's important to remember that the majority of people in China as well as India do not have health coverage and are not yet part of the pharmaceutical consumer market, especially for prescription drugs."  

1. PricewaterhouseCoopers, "Pharma 2020: The Vision," (New York, 2007).  

Recent reports discuss the future of pharma's emerging markets.

A Reality Check on Emerging Markets

The US Food and Drug Administration will have a $2.1 billion budget next year if the fiscal year 2009 bill markup by the US House of Representatives’ Agriculture Appropriations Subcommittee passes through Congress. The subcommittee approved for FDA $282 million above the President’s budget request for FY 2009.

In her opening statement at last week’s meeting, Subcommittee Chairwoman Rosa DeLauro (D-CT) noted that the administration had recently made a request for an additional $275 million for FDA [

]. “To be sure, this is a long overdue acknowledgment that the 

 is not working when it comes to our broken food safety system,” she said. “So we are indeed, eager to fully fund that request and provide the critical resources necessary for reform.”

DeLauro added her concern that the administration has yet to indicate how FDA should use these additional funds. “…Real reform requires real management – so this committee will convene hearings and require spending reports to ensure the money is used as effectively as possible,” she said.

The marked-up Subcommittee bill goes to the House Appropriations Committee next where it will be further reviewed and marked up before going to the full House of Representatives. 

The US Food and Drug Administration will have a $2.1 billion budget next year if the fiscal year 2009 bill markup by the US House of Representatives' Agriculture Appropriations Subcommittee passes through Congress.

House Subcommittee Approves $2.1 Billion for FDA

With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process. The HHS’ Office of Inspector General issued a report on the FDA’s generic-drug review process this month, advising the agency to better prioritize its review system.

By law, pharmaceutical companies must submit ANDAs to FDA’s Office of Generic Drugs (OGD) and receive agency approval before marketing new generic drugs. FDA has 180 days to review and approve or disapprove each ANDA. Current practice involves review by three OGD divisions: chemistry, bioequivalence, and labeling. The office’s microbiology division also reviews some ANDAs. All applications are reviewed on a first-come basis, except for those deemed to have no deficiencies by the chemistry division or those that have minor deficiencies, and are therefore fast-tracked through the other divisions. The chemistry division is the primary division to issue disapprovals based on chemistry deficiencies in companies’ applications, according to the HHS report. 

The number of ANDAs has increased 158%, from 307 to 793, between fiscal year 2001 and fiscal year 2006, according to the report. During the same time period, OGD’s full-time positions increased by only 50%, from 134 to 201. The office’s funding increased by 74%, from $35.9 million to $62.6 million, between 2001 and 2006.

HHS looked at 989 original ANDAs under review in 2006 and interviewed OGD division reviewers and officials. Their findings show that, in 2006, FDA:

Approved or tentatively approved 4% of original      ANDAs under review; the remaining 96% were disapproved



Exceeded the 180-day review requirement for      nearly half of the original ANDAs under review because the chemistry      division’s reviews exceeded 180 days
    
  

Microbiology, bioequivalence, and labeling      division reviews exceeded 180 days
    
  

Nearly 70% of sampled division reviews exceeding      the 180-day requirement did not begin before the 180-day review period      expired.

Based on this information, HHS recommends that FDA: 

Identify common      original ANDA deficiencies and offer more guidance to industry to decrease      the percentage disapproved 

Increase the      percentage of original ANDA reviewed by all divisions within 180 days

Identify new prioritization practices to reduce      review times for ANDA close to approval.

In response, FDA has said it has already identified and is implementing portions of HHS’ recommendations, but it was not clear at press time whether the agency agrees with all of the report’s suggestions.

 by the HHS' Office of Inspector General.

With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process.

HHS Targets FDA's Generic Drug Reviews

The number of clinical-trial investigators overstepping their bounds has grown in the past few years. And, says Congress, the US Food and Drug Administration is taking too long to wrap up unresolved cases.

In addition to regulating the safety and effectiveness of drugs, FDA oversees the conduct of doctors and clinicians who carry out drug studies. Clinical-study investigators are required to follow certain statutes and regulations to ensure the integrity of their data and to protect individuals participating in the trials. 

The agency has disqualified more than 130 such investigators since 1964. Twenty-five of those have been disqualified since 2001, and seven of them were disqualified in the first half of this year. 

Beyond the fact that the number of disqualifications seems to be on the rise, some Congressman are concerned that cases remain open too long-as much as a decade, according to 

US Reps. Joe Barton (R-TX) and John Shimkus (R-Ill.) have been wrangling the Government Accountability Office (GAO) to push FDA to take action against corrupt researchers more quickly.

  “The FDA’s delay in initiating disciplinary proceedings is a critical one, as clinical investigators who have engaged in misconduct are still eligible to receive investigational drugs until the FDA disqualifies them,” the Representatives told the GAO in a letter dated March 11, 2008. 

, the agency has 12 pending disciplinary action suits against researchers who allegedly violated rules to protect patients and ensure accurate data.

FDA has the right to disqualify or “totally restrict” a clinical-study investigator from conducting further research if he or she repeatedly or deliberately fail to comply with current requirements, or if the researcher repeatedly or deliberately submits false information to the trial sponsor or to FDA itself. Once disqualified, the researcher can no longer receive investigational drugs, biologics, or devices. 

FDA can also apply a lesser “restricted” classification to individuals. These investigators are still able to work with investigational products, but they have some limitations which are they agree to with FDA. The agency can elect to reinstate researchers.

The latest person to receive the so-called Scarlet letter, is Maria Anne Kirkman Campbell, who pleaded guilty to fraud in 2003 after working on a 

.  Even though her case took place five years ago, Campbell just received her disqualification status last month.

www.fda.gov/ora/compliance_ref/bimo/disqlist.htm