Senator Collins Introduces Greater Access to Affordable Pharmaceuticals Act

Ms. COLLINS. Mr. President, I am pleased to join my colleagues from New York and Arizona in introducing the Greater Access to Affordable Pharmaceuticals Act, which will make prescription drugs more affordable by promoting completion in the pharmaceutical industry and increasing access to lower-priced generic drugs. The bipartisan bill that we are introducing today is identical to the compromise legislation that overwhelmingly passed the Senate last July by a vote of 78 to 21. That compromise was based on an amendment I Offered in the Health, Education, Labor and Pensions Committee with my colleague form North Carolina, Senator Edwards.

Prescription drug spending in the United States has increased by 92 percent over the past 5 years to almost $120 million. These soaring costs are a particular burden for the millions of uninsured Americans, as well as those seniors on Medicare who lack prescription drug coverage. Many of these individuals are simply priced out of the market, or forced to choose between paying the bills or buying the pills that keep them healthy.

Skyrocketing prescription drug costs are also putting the squeeze on our Nation's employers who are struggling in the face of double-digit annual premium increases to provide health care coverage for their workers. And they are exacerbating the Medicaid funding crisis that all of us are hearing about from our Governors back home as they struggle to bridge growing shortfalls in their State budgets.

The legislation that we are introducing today will make prescription drugs more affordable for all Americans. The nonpartisan Congressional Budget Office estimates that are bill will cut our Nation's drug costs by $60 billion over the next 10 years. That is why the legislation is supported by coalitions representing the Governors, insurers, businesses, organized labor, senior groups, and individual consumers who are footing the bill for these expensive drugs and whose costs for popular drugs like Cardizem CD, Cipro, Prilosec, and Zantac could be cut in half if generic alternatives were available.

The 1984 Hatch-Waxman Act made significant changes in our patent laws that were intended to encourage pharmaceutical companies to make the investments necessary to develop new drug products, while simultaneously enabling their competitors to bring lower-cost, generic alternatives to the market. To that end, the legislation has succeeded to a large degree. Prior to Hatch-Waxman, it took 3 to 5 years for generics to enter the market after a brand-name patent had expired. Today, lower-cost generics often enter the market immediately upon the expiration of the patent. As a consequence, consumers are saving anywhere from $8 to 10 billion a year by purchasing generic drugs.

Moreover, there are even greater potential savings on the horizon. Within the next 4 years, the patents on brand name drugs with combined sales of $20 billion are set to expire. If Hatch-Waxman were to work as it was intended, consumers could expect to save between 50 and 60 percent on these drugs as lower cost generic alternatives become available as these patents expire.

Despite its past success, however,it is becoming increasingly apparent that the Hatch-Waxman Act has been subject to abuse. While many pharmaceutical companies have acted in good faith, there is mounting evidence that some brand name generic drug manufacturers have attempted to "game" the system by exploiting legal loopholes in the current law.

Too many pharmaceutical companies have maximized their profits at the expense of consumers by filing frivolous patents that have delayed access to lower priced generic drugs. Currently, brand-name companies can delay a generic drug from going to market for years. A "new" patent for an existing drug can be awarded for merely changing the color of a pill or its packaging. For example, Bristol Myers-Squibb delayed generic competition on Platinol, a cancer treatment, by filing a patent on the brown bottle that it came in.

Another example cited by the Chairman of the Federal Trade Commission, Timothy Muris, in testimony before the Senate Commerce Commission, involved the producer of the heart medication Cardizem CD, which brought a lawsuit for patent and trademark infringement against the generic manufacturer in early 1996. Instead of asking the generic company to pay damages, however, the brand name manufacturer offered a settlement to pay the generic company more than $80 million in return for keeping the generic drug off the market. Meanwhile, users of Cardizem—which treats high blood pressure, chest pains and heart disease—were paying about $73 a month when the generic would have cost about $32 a month.

Last July, the Federal Trade Commission released a long-awaited report that found that brand-name drug manufacturers have misused legal loopholes to delay the entry of lower-cost generics into the market. The FTC found that these tactics have led to delays of between four and 40 months—over and above the first 30-month stay provided under Hatch-Waxman—for generic competitors of at least eight drugs since 1992. Moreover, six of the eight delays have occurred since 1998.

The FTC report points to two specific provisions of the Hatch-Waxman Act—the automatic 30-month stay and the 180-day market exclusivity for the first generic to file a patent challenge—as being susceptible to strategies that could delay the entry of lower-cost generics into the market. According to the report, these loopholes "continue to have the potential for abuse," and, if left unchanged, "may have more significance in the future." These are the very loopholes that the legislation we are introducing today would close.

The original Hatch-Waxman Act was a carefully constructed compromise that balanced an expedited FDA approval process to speed the entry of lower-cost generic drugs into the market with additional patent protections to ensure continuing innovation. The bipartisan bill that we are introducing today restores that balance by closing the loopholes that have reduced the original law's effectiveness in bringing lower-cost generic drugs to market more quickly, and I urge all of my colleagues to join us as cosponsors.