Senate panel OKs bill improving generic drug access

WASHINGTON – Bipartisan legislation sponsored by Sens. Susan Collins, R-Maine, and John Edwards, D-N.C., aimed at bringing down the price of prescription drugs cleared a key Senate panel Thursday.

Approved by the Senate Health, Education, Labor and Pensions Committee on a 16-5 vote Thursday, the bill, which seeks to ease market access for generic drug producers, is expected to go to the Senate floor early next week for full debate. It likely will be dovetailed with proposals to create a new Medicare drug benefit for seniors.

As crafted, the Collins-Edwards measure seeks increased market competition by making it more difficult for brand-name drug manufacturers to prevent or delay generic drug manufacturers from entering the market with less expensive copycat drugs.

Collins said the legislation would serve consumers who must bear the brunt of sky-rocketing drug costs, businesses that face escalating medical insurance costs for their employees, and state governments that must pick up the tab on public health costs.

“Soaring costs are a particular burden for the millions of uninsured Americans as well as for those seniors on Medicare who lack prescription drug coverage,” she said.

“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.”

Under a current law, known as the Hatch-Waxman Act, brand-name manufacturers are granted a 30-month patent protection extension on their products for each patent application they file on a product.

Lawmakers, including Collins, and with national consumer groups routinely have accused drug companies of abusing that patent law, which was passed in 1984. They say brand-name drug producers work to obtain secondary patents with dubious claims of innovation that tie up generic drug suppliers in litigation and delay competition from entering the market.

One commonly cited example is the case of Nicorette gum, whose makers filed a patent on its new mint flavor in order to fend off competition from generics.

The proposed legislation would limit brand names to a single 30-month stay beginning at the time of product approval.

The measure amends the present law, which set out to strike a balance between competition in the pharmaceuticals market and patent protection for brand name innovators.

Many view that law as outdated, citing the ever-increasing prescription drug costs and the inability of seniors and others to pay for them.

“The average prescription price grew last year at more than three times the inflation rate, and the prices of many popular drugs increased by more than 10 percent,” Edwards said in a press release.

Opponents of the bill, including brand-name manufacturers, complained about provisions they said would undermine the current patent system that has encouraged medical innovation. They cited recent advances in drugs for treating heart disease, high blood pressure, cancer and Alzheimer’s disease. By removing checks on generic market entry, brand names have less incentive to invest in research and development.

“Since [Hatch-Waxman}, over 8,000 new drugs have come on to the market, 94 percent of which have had a smooth transition to the generic market,” said Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, whose members include brand-name drug makers. “Generic market share has increased from 19 percent to 43 percent in the past decade,” he said.

PhRMA also asserts that innovative drug manufacturers lower overall health care costs by reducing the length of hospital stays, nursing home stays, and surgical costs.