This plan is similar in nature in many ways to the Clinton plan and like that campaign, is also more comprehensive when compared to many of the other candidates. That said, the focus was even more placed on insurance – which calls for "Universal Health Care Through Shared Responsibility," with little mention of the concerns that may be specific to the pharmaceutical market place. In other words, long on insurance, short on our substance. Since the plan was issued, he has made several issue comments in press releases, but without updating the plan.
I am evaluating at the plans and candidate positioning regarding five domains:
- Importation of Drugs – Many opponents of importation are likely to see a contradiction in his positioning on this issue. On the one hand, "Edwards will station permanent FDA inspectors to conduct spot inspections in all countries with significant imports, starting with China and India. He will also demand that China regulates is chemical exporters and require "track and trace" pedigrees on all drugs to fight counterfeits." So, while there is a dedication to safe importation, he supports importation…"Edwards has long supported the safe reimportation of prescription drugs from Canada, which could save consumers $50 billion over 10 years. [Washington Post, 5/3/07] "
- Medicare Part D Reform – While nothing specific was found about the negotiation of drug pricing by the government in the plan, he has stated that "Edwards will repeal the law preventing Medicare from negotiating drug costs with drug makers and empower states to use Medicaid’s leverage to purchase drugs at lower prices, with safeguards to preserve access. ."
- Pharmaceutical Marketing Restrictions - John Edwards believes that a large part of the rising cost of drugs is direct to consumer advertising. His plan states that "Edwards will restrict direct-to-consumer advertising for new drugs to ensure that consumers are not misled about the potential dangers of newly marketed drugs …" The candidate has also called for a ban on DTC advertising during the first two years after a drug enters the market. In fact, in October he outlined four steps regarding DTC and marketing practices that involve restrictions and closer oversight:
- Delay New Ads to Put Safety First: Edwards will institute a two-year delay on consumer advertising of all new drugs.
- Get Control with Real Oversight of Advertising: Edwards will give the Food and Drug Administration real power to prevent misleading drug ads by requiring the agency’s approval before drug companies can launch major ad campaigns and by increasing the penalties for drug companies that violate truth-in-advertising laws.
- Require "Whole Truth" Disclosures: Edwards will improve drug makers’ disclosures to the public, requiring companies to tell the public the whole truth about side effects and how effective drugs are against placebos and existing alternatives.
- Help Doctors Make Decisions Based on Evidence, Not Ads: Edwards will establish a non-profit or public organization to research the best methods of providing care.
5. Follow-on-Biologic Regulation – Nothing found other than the fact that he would allow the FDA to approve "biogenerics", but see below..
6. Generic Promotion – Again with no specificity in his plan, he has made statements that favor competition. Under the sub-heading "Promoting Evidence Based Medicine" he states that "doctors sometimes prescribe name-brand drugs despite the availability of equally effective, less expensive generic drugs." However, he does nothing to say whether he supports substitution without the physician’s knowledge.
Analysis: While he does not offer specifics in these five domains in the plan, looking through his press releases, one finds that he and Senator Clinton are probably on the same page when it comes to health care reform in all five domains. If elected, his presidency would seriously transform the drug market place, allowing importation (albeit safe), He does sound a note, however, of criticism of the industry and the FDA when he closes the plan by saying that he would "strengthen the Food and Drug Administration’s ability to monitor new drugs after they reach the marketplace. He will also ensure that researchers evaluating medical devices and drugs are truly independent." The tone of the statement indicates a candidate who, while not speaking to the specifics outlined above, is probably like to take positions once elected that run counter to those of industry. In other words, reform is the true objective here and that reform is not likely to emulate the positions staked out by industry, and in some cases, maybe even the FDA itself.
The candidate has a blog where you might read more.