Generic News

DECEMBER 11, 2011

Lawmakers, Industry Weigh Changes to Hatch–Waxman

The law that governs generic drugs’ path to market was under the microscope last month, as elected officials and pharmaceutical manufacturers each sought ways to tweak it to their advantage.

Introduced to spur generic competition, the 1984 Hatch–Waxman Act grants 180 days of marketing exclusivity to the first generic company to successfully challenge a drug patent. The Generic Pharmaceutical Association (GPhA) says the law has worked “far better than anyone could have ever imagined,” encouraging innovation of new medicines while increasing accessibility to generics.

As health care continues to evolve, however, many argue that the Hatch–Waxman Act should be amended to reflect the new landscape of drug research and development. Measures proposed separately—one described in a November report in the journal Health Affairs and another outlined in a new bipartisan bill—would do just that.

The Health Affairs report, written by Duke University economist Henry G. Grabowski, PhD, was funded in part by the Pharmaceutical Research and Manufacturers of America. In it, Dr. Grabowski noted that the average period of exclusivity for brand drugs has shortened significantly since 1984. In light of this finding, he called on Congress to “review whether Hatch– Waxman is achieving its intended purpose of balancing incentives for generics and innovation.”

In a swift response to the article, GPhA decried 2 changes Dr. Grabowski recommended for the Hatch–Waxman Act: a 7-year increase in the exclusivity period for brand drugs and the elimination of the initial 180-day exclusivity period for first-to-market generics. “If the reckless recommendations in this report are followed,” GPhA stated, “the historic Hatch–Waxman Act would be gutted.”

Ending privileges for first-to-market generics is also central to the FAIR GENERxICS Act of 2011, a bill introduced November 16, 2011, by US Senators Jeff Bingaman (D-NM) and David Vitter (R-LA). By eliminating the 180-day exclusivity period for new generics, the legislation aims to bring an end to “pay for delay” patent settlements.

Critics see the deals as anticompetitive, benefiting generic “first-filers” and brand pharmaceutical manufacturers while delaying patients’ access to affordable generic medicines. According to Senator Bingaman, the new bill is a simple fix for a thorny problem that has plagued the Federal Trade Commission for years. “We need a federal law in place that encourages competition, not collusion,” he said.

GPhA maintains that patent settlements speed access to generic medicines, and remains staunchly opposed to any changes to the Hatch–Waxman Act. “Rather than taking the treacherous steps of revisiting a successful policy,” said GPhA’s president and chief executive officer Ralph G. Neas, “we should be focusing on mirroring these remarkable accomplishments in the regulation of biogenerics.”


Cost Burden Is Heaviest for Sick Americans

Bargain $4 generics may save patients a few dollars at the pharmacy, but a new report finds the sickest Americans face much bigger challenges when it comes to paying for care.

Compared with similar patients in other high-income countries, Americans with chronic diseases are more likely to be saddled with debt from medical bills and skip treatments due to cost, according to survey results released in November by the Commonwealth Fund. The problem is concentrated in younger patients, who experience greater financial hardship than seniors covered under Medicare, analysts noted.

The international poll of 18,000 patients in 11 highly developed nations showed that, among Americans with serious health problems:

• More than 2 in 5 (42%) reported not visiting a doctor, not filling a prescription, or not getting recommended care—twice the rate of most countries polled. For those younger than 65 years old, the number increased to half (51%), compared with just 6% of adults 65 years and older with Medicare coverage.

• More than 1 in 4 (27%) said they could not pay, or had serious problems paying, medical bills. The number increased to 35% in adults younger than 65 years, compared with 19% of seniors 65 years and older. In the 10 other countries polled, the number ranged from 1% to 14%.

• More than one-third (36%) spent more than $1000 on out-of-pocket medical costs, compared with fewer than 10% in France, Sweden, and the United Kingdom.

The troubling trends indicate a misguided use of resources as the nation’s health care expenditures continue to increase, according to Karen Davis, president of the Commonwealth Fund.

“Despite spending far more on health care than any other country, the United States practically stands alone when it comes to people with illness or chronic conditions having difficulty affording health care and paying medical bills,” she said.

The complete Commonwealth Fund report is available at http://phrmcyt .ms/srBHPv. PT 

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