Amy Ritter was Scientific Editor, BioPharm International.

Amy Ritter, PhD

The spate of large mergers that dominated the news a few years ago seems to be slowing, but bio/pharmaceutical companies still face pressure to run leaner businesses and to see a better return on investment from their R&D divisions. The global economy continues to limp along, and pharma faces pricing pressure from cost-conscious payers and from developing countries determined to hold the line on drug prices. The industry continues to adapt to this challenging business environment, and these challenges cannot help but affect pharma employees. 

 asked readers about their employment situations:  how secure they felt in their positions, how satisfied they are with their jobs, and how they see the future of their companies and the global industry. The following pages highlight key results from the survey. 

 PHOTOGRAPHY BY DAN WARD; MIKE HARRINGTON/GETTY IMAGES 

The level of employment insecurity is dropping among biopharma employees. Year over year, fewer respondents say they feel less secure in their positions than they did the year before. In 2010, 53% said they felt less secure. This dropped to 41% in 2011, and this year, only 34% were feeling less secure. While this seems encouraging, readers did not say they felt more secure. Instead, an increased percentage (47% this year) said they felt about the same as last year. It seems, then, that pharma employees are becoming accustomed to the new, more fluid business environment. Is insecurity becoming the new normal? Perhaps, but respondents felt confident they would be able to find a new job if they had to, and they continue to derive satisfaction from the intellectual stimulation and challenging projects associated with their jobs.  

The difficult economic climate is being felt by those in the industry. A third of respondents, 33%, indicated that business had declined over the past year. Yet, respondents were upbeat about the future, both for their own companies and for the industry as a whole. Only 34% expect business at their own companies to decline next year, with the rest expecting either no change (18%), or an increase (48%).  When asked about the industry as a whole, 49% said they expected business to improve. Next year will bring its own set of challenges for the industry, but let's hope that this optimism is well founded.  

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Annual employment survey results show greater confidence in the pharma industry.

Job Security

 that it has received FDA approval for a seasonal influenza vaccine produced in cell culture. The vaccine, Flucelvax, is approved for use in individuals 18 years of age or older.  According to the company press release, cell-culture technology has been successfully used to manufacture other vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella, and hepatitis, but Flucelvax is the first seasonal vaccine produced by this method to be approved in the US. The virus for the vaccine is produced under closed, sterile conditions in a well-characterized mammalian cell line, rather than in chicken eggs.

Novartis partnered with the US Department of Health and Human Services and the Biomedical Advanced Research and Development Authority to develop the cell-culture manufacturing technology, as well as to construct a manufacturing facility in Holly Springs, NC. Total public/private investment in the technology development and facility is more than $1 billion. Flucelvax will be produced in Holly Springs once the facility is ready for full-scale commercial production. 

In the release, Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics, said, "Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way."

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

First Seasonal Influenza Vaccine Produced in Cell Culture Approved in US

 the availability of the guidance “Q11 Development and Manufacture of Drug Substances” in the Nov. 20, 2012 edition of the

. The guidance was prepared under the auspices of the International Conference on Harmonization (ICH) and describes approaches to developing and understanding the manufacturing process of a drug substance, as well as providing guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information in the European Union, Japan, and the US.

According to the announcement, the final guidance contains revisions to the introduction and process development sections of the draft version of the guidance to more strongly emphasize that purification processes play a significant role in drug substance manufacture. The final guidance also incorporates revisions to the discussion of design space for chemical entities and biotechnological/biological drug substances, and revisions to the discussion of control strategy.

FDA announced the availability of the guidance â€œQ11 Development and Manufacture of Drug Substancesâ€ in the Nov. 20, 2011 edition of the Federal Register.

FDA Adopts Final Version of Q11 Guidance

In the wake of congressional hearings into the events leading up to an outbreak of fungal meningitis caused by contaminated compounded medicines, House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

Specifically, the legislators have asked for an investigation into Group Purchasing Organizations (GPOs), entities that negotiate drug and device prices for large operations, such as hospitals.  In a 

 sent to the head of the GAO, the legislators ask whether anticompetitive, exclusionary contracts between GPOs and generic drug manufacturers coupled with high fees have created a disincentive for manufacturers to produce some of the generic sterile injectables that are currently in shortage, causing hospitals and clinics to obtain them instead from compounding pharmacies.  The letter points out that the drug at the root of the meningitis outbreak, methylprednisolone acetate, is currently in shortage.

Specifically, the letter’s authors ask the GAO to investigate:

What impacts have contracting practices by manufacturers, GPOs, and providers had on access, competition and innovation, and pricing of devices and drugs?

What market factors contribute to the reliance of hospitals and other health care providers on compounding pharmacies?

Do drug shortages drive hospitals and other health care providers to a greater reliance on products from compounding pharmacies?

Do incentives in the current GPO model lead to inflated prices for drugs and devices?

What is known about the impact that GPO administrative fees have had on generic drug manufacturers’ financial condition, their ability to maintain and upgrade plant equipment, and their ability to maintain quality control?

, Rep. DeGette (D-CO) said, “In the drug shortage crisis of recent years, doctors and hospitals were increasingly forced to turn to compounding pharmacies like the one that caused the devastating meningitis outbreak. While we've begun to address drug shortages legislatively, it is clear we must aggressively investigate the factors that led to this deadly outbreak and determine possible remedies, so we can take steps to save patients lives.”

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

Legislators Request Info on Link Between Drug Shortages and Increased Reliance on Compounding

Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak. The purpose of the hearing was to determine why contaminated medicines entered the supply chain so that future occurrences could be prevented. Hamburg’s prepared

 focused on FDA’s response once the meningitis outbreak had occurred. The statement asserted that the laws governing compounding pharmacies, even large ones such as the New England Compounding Center (NECC), are ambiguous, thus limiting FDA’s ability to oversee such enterprises. In the statement, Hamburg requested legislation that would place nontraditional compounding pharmacies producing certain types of high-risk products under FDA oversight. The proposed legislation would allow FDA the same ability to inspect facilities and review records as the agency does for pharmaceutical manufacturers.

		While Hamburg’s testimony was focused on the future, the representatives on the committee were visibly frustrated by her unwillingness to deconstruct the past, and identify steps that could have been taken to prevent the incident from occurring. Hamburg doggedly stuck to her explanation that FDA’s authority over compounding pharmacies was unclear. If FDA had no authority over large-scale compounding, this explanation might have been better accepted. However, FDA had issued warning letters to NECC in the past for matters not related to sterile manufacturing, and FDA certainly had the authority to inspect the facility and shut it down once the source of contamination had been identified.

		Hamburg’s request for new legislation clarifying FDA oversight for nontraditional compounding pharmacies was well received, and I think we can expect to see such legislation in the near future. However, many of the committee members were clearly not satisfied that FDA had done everything it could, even considering its limited oversight responsibilities, to protect public health.

Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak.

A Tough Time for FDA at House Hearings

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines. The drugs seized included antimalarials, antibiotics, cough medicines, contraceptive pills, and fertility treatments, and were valued at around $40 million.

The operation was conducted simultaneously at 16 major seaports on the east and west coasts of Africa between July 11, 2012, and July 20, 2012. Customs officials seized more than 100 million counterfeit products of all categories. Of a total of 110 shipping containers inspected, 84 contained counterfeit or illegal products, with the largest shipments found in Angola, Togo, Cameroon, and Ghana. The majority of the shipments originated from South Asia, East Asia, and the Middle East.

 from IRACM and WCO, customs officers involved were trained by WCO, with the support of IRACM and experts from the pharmaceutical sector, to recognize the technical characteristics of various products that are subject to counterfeiting and to implement new detection methods. According to the release, the organizations expect to extend the operation to other continents in the coming months.

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.