Senate moves on generic drug bill

Senate Votes to Give Consumers Faster Access to Generic Drugs

The Senate overwhelmingly approved a proposal today to give consumers swifter access to low-cost copies of brand-name prescription drugs.

It also turned back a Democratic effort to limit the premiums that could be charged for new prescription drug benefits under Medicare.

The 94-to-1 vote on generic drugs came just minutes after the 56-to-39 vote on Medicare premiums.

Both proposals were offered as amendments to a sweeping bill that would add drug benefits to Medicare and fundamentally restructure the program, which provides health insurance to 40 million people who are elderly or disabled.

We will have a Medicare drug bill. The political forces that favor this bill are too strong to stop a bill.

Will we have the right bill? Probably not, but one can argue that this imperfect bill will improve patient health. Back to the generic issue:

House Republican leaders have shown little interest in such generic drug legislation. But Mr. Schumer said it would be difficult for them to kill the proposal in the expected conference committee to iron out differences on the overall Medicare bill.

Mr. Schumer said the generic drug proposal could save consumers $60 billion to $70 billion in the next decade and could reduce Medicare costs by $18 billion to $20 billion. The proposal goes beyond new rules issued last week by the Food and Drug Administration, which took its own action to make generic drugs more accessible. In recent years, Mr. Schumer said, brand-name drug companies have used “frivolous patents, lawsuits and legal mumbo-jumbo” to delay the marketing of generic drugs.

The Gregg-Schumer proposal would limit the ability of brand-name drug companies to delay federal approval of competing generic drugs. Brand-name manufacturers would be allowed only a single 30-month stay, while a court tries to resolve patent disputes. Brand-name companies have sometimes blocked competition for much longer, by filing additional patent claims and piling 30-month stays on top of one another.

The measure would also bar collusive agreements under which brand-name drug companies pay generic companies to keep generic drugs off the market.

The existing law provides an incentive for generic drug companies to challenge patents that may be invalid. If they are successful, such companies have the exclusive right to market the generic drug for 180 days, but sometimes the drug never reaches the market. Under the Gregg-Schumer proposal, generic drug companies would have to market the drug in a timely way or lose their 180-day protection.

This bill should fix a system that has meandered from original intent. We want the pharmaceutical industry to have sufficient incentives to produce new drugs. They deserve some patent protection. Where I (and many physicians) object is the legal games that the industry plays to extend patent protection beyond the time the law allows. This drug should close some legal loopholes. Patients will benefit.