Issues and Opportunities Challenge Biotech Manufacturers

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.
Jan 01, 2010
Volume 23, Issue 1

Jill Wechsler
After a year of considerable turmoil in Washington policy and regulatory circles, there is optimism that healthcare coverage and requirements for medical product development will gain some clarity in the coming months. National health reform legislation either will become law in some form, or die. The new team heading up the US Food and Drug Administration will be firmly established and eager to implement new policies and programs. These developments will shape a number of key trends and developments in 2010 of importance to biotech manufacturers.


International funding of a vaccine to combat the H1N1 influenza pandemic has spurred construction of new vaccine manufacturing facilities in the US and abroad, and that trend is not likely to diminish. Manufacturer interest in expanding sales in newly industrialized nations has spurred worldwide support for research on new vaccines and for treatments for malaria, tuberculosis (TB), and neglected tropical diseases, along with investment in foreign manufacturing facilities and new vaccine production and testing methods. Vaccines to combat malaria and TB are in clinical trials, and scientists remain optimistic about moving forward with the long-sought vaccine to prevent HIV infection. An anti-smoking vaccine is moving into late-stage testing, while scientists continue to seek therapeutic vaccines for cancer and other conditions.

The FDA is supporting such efforts, particularly development of new TB treatments to replace ineffective old therapies and to help counter a resurgence in drug-resistant TB strains. And to better monitor the growing volume of food items and medical products imported to the US, the FDA is establishing overseas offices and doubling the number of foreign inspections it conducts each year. New legislation to overhaul food safety would further expand FDA inspections of food facilities in the US and abroad. In addition, the FDA is partnering with European regulatory authorities to share inspection information and conduct joint inspections of foreign active pharmaceutical ingredient producers, an initiative that could expand if beneficial.


Longer supply chains and rising imports raise questions about the ability of drug manufacturers to ensure the quality and safety of biomedical therapies. Because the FDA can never check all of the thousands of products coming into the US, the agency expects manufacturers to do more to ensure that contractors and suppliers have a commitment to quality, and that they are routinely monitored and inspected. The aim is to prevent future adulteration crises, such as those involving heparin, melamine, and DEG-contaminated glycerin in medical products.

Along these lines, the FDA's Center for Drug Evaluation and Research (CDER) continues to emphasize the importance of manufacturer Quality by Design (QbD) and risk management systems to ensure drug quality. CDER officials are evaluating a QbD review pilot and launching a similar initiative for biotech therapies. Additional efforts to harmonize quality standards are under discussion. An electronic drug registration and listing system was fully implemented this past year and should make it easier for the FDA to identify and track products and manufacturing facilities.


The FDA also is involved in multiple initiatives to encourage the safe use of medicines. The FDA Amendments Act of 2007 (FDAAA) authorizes post-approval label changes when new safety issues arise and action against manufacturers that fail to conduct agreed-on post-marketing studies. There are mandates for more extensive listing of clinical trials and study results on the public web site and for Risk Evaluation and Mitigation Strategies (REMS) governing post-market prescribing and surveillance. The FDA has approved REMS for almost 90 products and is developing a REMS for the entire class of extended-relief opioid medicines. Manufacturers will be watching to see how well these programs detect and prevent drug safety problems and if that encourages FDA reviewers to approve products that raise some safety concerns.

Internally, the FDA is bolstering its safety assessment efforts through several initiatives. CDER's Safety First program is integrating oversight of drug safety issues by clarifying responsibility for pre- and post-approval drug safety assessment and strengthening safety-related policies and procedures. The agency's Sentinel Initiative is developing an electronic system for monitoring medical product safety. And the FDA's Safe Use initiative aims to build partnerships with other components of the healthcare system to ensure that medicines are used safely and appropriately. The FDA plans to partner with other government agencies and with healthcare providers to address situations that lead to medication errors and inappropriate prescribing.

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