Statments on Introduced Bills and Joint Resolutions

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

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Ms. STABENOW (for herself and Mr. LOTT):

S. 2300. A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.

Ms. STABENOW. Mr. President, I rise today to introduce the Lower PRICED Drugs Act. I want to thank Senator TRENT LOTT for joining me on this important legislation, and for his leadership in increasing the availability of affordable generic drugs.

I am very pleased that our legislation is supported by AARP, General Motors Corporation, AFL-CIO, Alliance for Retired Americans, Families USA, the Generic Pharmaceutical Association, the Pharmaceutical Care Management Association, PCMA, the National Association of Chain Drug Stores, and the Coalition for a Competitive Pharmaceutical Marketplace--an organization including large national employers and insurers.

We know that greater availability of generic drugs translates into dramatic savings for consumers, manufacturers, businesses, and taxpayers. Of the 25 top selling drugs in 2004, the only one that did not increase in price was a drug available both in generic and over-the-counter form. And, according to the National Association of Chain Drug Stores, while the average retail price for a brand drug in 2004 was $96.01 the average retail price for a generic was $28.74, a savings of nearly 70 percent.

It's a very well known principle of economics: competition lowers prices.

But we don't need to rely on economic theory; we only have to look at what is happening with drug prices. Of the top five brand name drugs, by retail sales, the average price for 1 month's use of the cheapest among them is just over $76, and the 3rd most popular drug--zocor--is more than $140 per month. That's $1,680 per year for an important drug to lower cholesterol levels. The average price of the most popular five drugs--none of which faces generic competition--is over $114.

There is nothing to hold down the prices of these drugs, and in fact, even though many of them have been on the market for years and years, their prices continue to increase. I first checked the prices of these drugs last November, and then again on Monday of this week. The prices this week are higher, by several dollars in many cases, than they were last year.

However, consider the prices consumers pay for drugs for which there are generic equivalents. The most frequently dispensed generic drugs are hydrocodone, lisinopril, atenolol, amoxicillin and hydrocholorothiazide. Not only are these important drugs, used to treat pain, high blood pressure, and bacterial infections, considerably more affordable than their brand name equivalents, the average generic price is $9.34, representing a savings of more than 60 percent from the average brand price of $24.74, but the presence of competition has another important effect: The average price of these brand name drugs is a lot lower than the average price of brand drugs that don't face competition.

While the generic provisions in the Medicare Modernization Act, MMA, made important progress, there still isn't timely competition in the pharmaceutical market.

New loopholes have been found to keep generics off the market, and keep prices higher than they need to be. In fact, in 2004, a year after AMA passed, brand name prescription drug prices rose by 7.1 percent, the biggest single-year price hike in 5 years.

Our bill would close several loopholes that prevent and delay generics from coming to market. It will increase access to affordable generic drugs and save consumers, businesses and Federal health programs billions of dollars annually.

The Lower PRICED Drugs Act would prevent abuse of the current pediatric exclusivity provision. It would ensure that pediatric exclusivity is used as intended, to generate information about the use of drugs in children, and prevent brand drug companies from keeping more affordable generic alternatives of drugs not suitable for children, or never studied in children, off the market.

For example, Pravigard PAC contains two widely used medications: pravastatin, used to lower cholesterol, and aspirin. Despite the fact that aspirin isn't safe in children, the manufacturer received a six-month pediatric extension. What sense does that make?

The manufacturer of Pravigard PAC even includes the following warning in the patient information they put out:

Who should not (manufacturer's emphasis) take PRAVIGARD PAC?

Do not take PRAVIGARD PAC if you: Are 18 years of age or younger. Children younger than 18 years should not use any product with aspirin in it.

Pediatric marketing extensions should not be given for products not suitable for children, like those containing aspirin.

Using pediatric marketing protections to extend brand name monopolies should be reserved for studies that help us learn more about drugs for kids, not to keep lower-cost generic alternatives of drugs for adults off the market.

Our bill would also remove an arbitrary roadblock to the entry of generic versions of certain antibiotics, close a loophole that allows drug companies to use the current complex rules for challenging drug patents as a delaying tactic against the introduction of generics and prevent abuses of the citizen petition process.

I look forward to working with Senator LOTT to create more competition, more choices, and more savings for American consumers of prescription drugs, and I urge colleagues to join us in this effort.

I ask unanimous consent to have the text of the bill and the letters of support we have received at this time printed in the RECORD.

There being no objection, the text of the material was ordered to be printed in the RECORD, as follows:

S. 2300

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