There are 65 days left to the Iowa Caucus. As I mentioned last week, I intend to profile the healthcare positions of each of the candidates as those positions might affect the workings of the FDA and the pharmaceutical market. While I originally was only going to consider candidates I considered top-tier, I am going to toss in the entire spectrum after some feedback by readers. The categories I am looking at are (1) importation of drugs, (2) Medicare Part D reform, (3) Pharmaceutical Marketing Restrictions, (4) Follow-on-Biologic regulation, and (5) Generic Promotion.
Senator Joseph R. Biden, Jr. (D-Del) is the first candidate to be considered. His plan for healthcare is listed at his Web site – www.joebiden.com and the name of the Biden plan is "Four Practical Steps Toward Health Care for All" and as the title implies, his plan is primarily focused on the issue of insurance reform. These four steps include covering all children, expanding access for adults, reinsurance for catastrophic cases and encouragement of prevention and modernization. Looking to the five categories:
- Importation of Drugs – not mentioned in his plan, however, in the past, he has voted in favor of importation from Canada.
- Medicare Part D Reform – In the last category of his Four Practical Steps – encouragement of prevention and modernization – a category that seems to be a collection of things that didn’t fit elsewhere, Senator Biden does include a provision for Medicare Part D reform. In this section of the plan, he states that the current law "dilutes" Medicare’s bargaining position and he uses the Veteran’s Administration health system as an example. The Senator would remove the provision of law that forbids the U.S. from negotiating.
- Pharmaceutical Marketing Restrictions – not mentioned.
- Follow-on-Biologic Regulation – not mentioned.
- Generic Promotion – not mentioned.
Analysis: In primarily focusing on insurance, this plan fails to address many of the issues of primary concern in healthcare, particularly those affecting development and innovation- and is not nearly as comprehensive as many others in the race. During the year, his votes indicate support for stricter oversight of industry with respect to post-marketing studies and other recommendations for reform made by the Institute of Medicine. Also in May, he failed to vote on an amendment to PDUFA legislation that would have allowed for the importation of prescription drugs nor did he vote on the issue of striking some provisions related to market exclusivity. His plan does not mention stem cell research, but he has voted in favor of amending the Public Health Service Act to provide for human stem cell research.
In his program’s fourth step – Encouraging Prevention and Modernization, it would be ideal if he would expand his thoughts on matters related to these issues, particularly as affecting the future development of medicines, filling in some of the blanks that his voting record does not clearly establish.
It is worth noting that Senator Biden the candidate also has a blog, but noticeably absent from the categories are the terms "prescription drugs", "drugs", "pharmaceuticals" or "healthcare".
Next candidate to be considered, taking them in alphabetical order, and with Sam Brownback (R-KS) having bowed out next – Senator Hillary Clinton (D-NY).
NOTE: THIS POSTING WAS UPDATED ON 12/10/07 TO REFLECT JOE BIDEN’S VOTING RECORD ON IMPORATION.