White House Health Proposal May Blow Up PhRMA Deal


This morning the White House released a new health care proposal that may be used as a blueprint for a compromise between House and Senate versions of reform. This new proposal will likely not find a receptive audience at the Pharmaceutical Research and Manufacturers of America (PhRMA)–the chief lobbying arm of the pharmaceutical industry.

Throughout 2009, PhRMA and major pharmaceutical companies crafted a deal with the White House to limit cost cutting by the industry in exchange for the industry’s support, through over $100 million in television advertising, for health care reform. (The entire story behind the crafting of the deal can be read here.) The White House’s new proposal contains deeper cost cuts than previously agreed to and contains regulations on the relationship between brand-name and generic drug companies that the industry opposes.

The deeper cost cuts come from an attempt to further close the “donut hole” in the Medicare Part D prescription drug program. The “donut hole” refers to the gap in coverage that occurs within Medicare Part D. For those purchasing prescription drugs through the program coverage cuts off at $2,700 spent and does not pick back up again until $6,154 is spent by the participant. The current language that was struck in the deal between the White House and the pharmaceutical industry maintains that drug companies would cover 50 percent of the cost for brand-name drugs for participants falling in the “donut hole.” This change would be implemented within the year. The White House’s new proposal would eliminate the “donut hole” by 2020 by making participants pay only 25 percent coinsurance with Medicare covering the other 75 percent. The White House also takes a page from the House health reform bill by providing a $250 rebate to Part D participants who fall into the “donut hole.” (The House bill provides for a $500 reduction in costs for participants who fall into the “donut hole.”)

Another piece of the proposal would allow the Federal Trade Commission (FTC) to regulate the interactions between brand-name and generic drug companies. At issue is the revelation that brand-name drug companies have been paying off generic drug companies for support on patent extensions for certain drugs. This means that consumers will see serious delays in the release of certain generic drugs and therefore still face the higher costs of brand-name drugs. The FTC is filing suit against the drug companies to end this practice and the White House proposal aims to give the FTC authority to regulate and end this practice. The summary of the proposal states that the White House would, “[make] anti-competitive and unlawful any agreement in which a generic drug manufacturer receives anything of value from a brand-name drug manufacturer that contains a provision in which the generic drug manufacturer agrees to limit or forego research, development, marketing, manufacturing or sales of the generic drug.” The White House claims that payouts to generic drug companies cost consumers up to $35 billion over the next ten years.

PhRMA and the brand-name drug companies backing it are adamantly opposed to FTC regulation of payouts to generic companies. A previous statement from PhRMA states:

Patent settlements between brand-name and generics companies can resolve expensive patent disputes to help foster innovation and improve access to medicines so that patients can live healthier, more productive lives.

Law and public policy have always favored settlements, including patent settlements. PhRMA continues to believe that legislation that would impose a blanket ban on certain types of patent settlements or otherwise prevent them could decrease the value of patents and reduce incentives for future innovation of new medicines. This is also unnecessary because the Federal Trade Commission (FTC) and others already have the authority to review and evaluate any patent settlement agreement between a brand name company and a generic company. The courts and enforcement agencies like the FTC are in the best position to review these settlements on a case-by-case basis to ensure that they are not harmful to competition. By imposing a general ban or imposing harsh disincentives, pending legislation would effectively remove the decision-making process from this appropriate venue.

After health care negotiations stalled in January, PhRMA President and CEO Billy Tauzin abruptly resigned. Media reports on his resignation have varied from differences in style that displeased the Board of Directors and displeasure with the failure of the deal struck with the White House to be adopted after a $100 million-plus advertising binge in support of the legislation. Since Tauzin’s departure, board members have continued the refrain that they will back the Senate legislation that contains the $80 billion cost cutting cap agreed to in the deal. PhRMA has yet to release a statement on the White House’s apparent abandonment of the previously agreed upon deal.