9. Leadership. Since President Bush took office, there has been only one year during which a confirmed commissioner held office.
8. Congressional Oversight. The Senate Finance Committee has held hearings, issued reports and letters, and begun investigations for a variety of FDA-regulated products.
7. Judicial Rulings. Various litigations, including the recent ruling in the Utah Medical case, could affect FDA's attitude toward industry. The Rx Depot and Lane Laboratories verdicts say FDA can order disgorgement and restitution with an injunction.
6. Drug-Device Combinations. As the number of combination products developed increases, the question of how to regulate them will have a direct effect on speed to market.
5. Good Business Enforcement. FDA has increased attention to the overall practices of a business, rather than the performance of individual products. Corporate warning letters and the Application Integrity Policy (AIP) could be costly for device makers.
4. Relationships with CDRH. The predictability, consistency, and quality of decisions made by CDRH have been questioned by industry. Fewer informal communications, a nonqualitative three-strikes policy, and arbitrary actions by the Office of Device Evaluation could all bear heavily on marketing.
3. Recalls and Physician Notices. The question of when to issue a recall is up for discussion. The Heart Rhythm Society recently said that even a single implantable cardioverter-defibrillator malfunction might be worthy of a notification to physicians.
2. MDUFMA. Industry needs to determine what improvements it is getting in return for its fees before reauthorization in 2007. Does FDA have meaningful performance goals, or are they using shortcuts in the system?
1. Guidant's Cautionary Tale. Regulatory violations, high-stakes finance, and media frenzy—Guidant's story has it all. The fallout should lead to increased awareness for other device companies. The entire industry must act to maintain people's trust.