Regulatory Watch

New scientific discoveries promise to expand treatments for rare and neglected diseases.

Comparative-effectiveness analysis aims to promote appropriate pharmaceutical spending.

Regulators face demands to improve postmarket surveillance and meet review deadlines.

Heparin contamination casts a shadow on regulatory oversight of product quality.

Quality-by-design submissions may reduce supplements and improve change management.

The rise in overseas manufacturing undermines FDA oversight of drug quality.

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.

To keep up with applications, FDA promotes new testing and administrative methods.

New FDA act reshapes drug development and marketing to restore public trust in pharmaceutical regulation.

Expanded access to drugs for seniors has increased demand and focused attention on costs.

User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.

FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.

Product characterization and production challenges are key issues in developing a pathway for biosimilar therapies.

Fewer field offices and inspectors will increase reliance on manufacturers to ensure product and process quality.

FDA is buried in postapproval manufacturing submissions and seeks to reduce the scope of changes that require agency scrutiny.

FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.

"Quality by design" (QbD) and "quality risk management" at long last seem to be moving from the buzzword stage to becoming important influences on drug development and manufacturing. A series of quality standards issued by the International Conference on Harmonization (ICH) is encouraging the adoption of common quality-based drug manufacturing approaches designed to reach the "desired state" of drug manufacturing (i.e., more efficient, agile, flexible operations that can reliably produce high-quality drug products with less regulatory oversight). These developments reflect increased pressure to make pharmaceutical manufacturing more efficient and less wasteful and to encourage regulators in all regions to focus on the most critical issues affecting product quality and patient safety.

Democrats are back on top in Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to needed treatments are high on the priority list. Manufacturers will be in the hot seat answering questions about patent practices, high-risk products, and why drugs cost less in other countries than in the United States. The real challenge, however, will be to gain approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on Sept. 30, 2007. Such legislation also would renew user fees for medical devices and continue the pediatric drug exclusivity program.

Brand-name manufacturers seek to protect their products.

FDA must monitor a growing number of facilities and complex drugs despite "resource challenges."

A recent analysis found that 9000 marketed drugs are not in FDA's National Drug Code Directory.

Partnerships launched 63 research projects that may translate into nine or 10 new drugs by 2010.

The new drug user-fee program will define how FDA does business over its next 100 years.

FDA is conducting laboratory research to understand better the ability of preclinical screening tests to identify potential risks and toxicities of nanotechnology-based drugs.

ORA leadership looks to staff redeployment and risk management to ensure product quality despite diminishing resources.

Manufacturing and formulation innovation spurs drug develop-ment, but raises new safety and quality issues.

The need to curb drug counterfeiting is spurring development of track-and-trace and product authentication technologies.

A new FDA policy emphasizes quality control over GMP compliance in producing clinical trial supplies.

FDA is proposing revisions to the drug user fee program while it weighs changes for drug safety initiatives and expanded vaccine production.

Manufacturers, FDA, and research organizations are collaborating on efforts to spur innovation and streamline drug production.