Κεντρική σελίδα Επίκαιρα θέματα Lawmakers Target Drug Prices With Ramped-up Competition

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Lawmakers Target Drug Prices With Ramped-up Competition

Washington Roundup

WASHINGTON With drug prices continuing their upward climb, several senators are launching bipartisan efforts to shoot them down with increased competition. And that's putting pay-for-delay settlements at the center of congressional crosshairs.

The most recent effort, introduced Wednesday, "fixes an unintended problem in the Hatch-Waxman Act," according to a press release from Sen. Jeff Bingaman's (D-N.M.) office. The problem was created by the first filer provision that awards 180 days' exclusivity to the first generic drugmaker to file an abbreviated new drug application (ANDA) for a specific drug.

In too many instances, the first-ANDA filer is paid by or settles a patent challenge with the brand company to delay selling the generic drug, extending the brand drug's monopoly of the market, opponents of such settlements argue. While the pay-for-delay settlements financially benefit both the brand company and the first filer, they block competition from other generics, delaying the market entry of cheaper drugs, the argument goes.

Bingaman's bill, the Fair and Immediate Release of Generic Drugs Act, S. 1882, modifies the first filer provision to allow other generics to share the 180-day exclusivity if they've won a patent challenge against the brand drugmaker in district court or they have not been sued by the brand maker.

S. 1882 targets pay-for-delay settlements by preventing "parked exclusivities" from delaying competition. At the same time, it would hold a generic company to the deferred entry date it agreed to in any settlement reached with the brand company.

Subsequently, a first filer that agreed to a pay-for-delay settlement could actually be the last to market with its generic. That possibility could dampen generics' enthusiasm for the settlements, the sponsors of the bill reason.

"At a time when Americans are struggling to make ends meet, the cost of prescription medications is outpacing inflation. We need a federal law in place that encourages competition, not collusion," Bingaman said, adding that S. 1882 would "bring a level of fairness to the pharmaceutical industry."

In introducing the bill, Bingaman pointed out that 2008 spending on prescription drugs in the U.S. hit $234.1 billion, six times the $40.3 billion spent in 1990. The federal government picked up the tab for 30 percent of the 2008 drug bill, but its share is expected to increase to 40 percent by 2018.

The bill is seen as a complement to the Preserve Access to Affordable Generics, S. 27, that was introduced in January by Sens. Herb Kohl (D-Wis.) and Chuck Grassley (R-Iowa). S. 27 prohibits brand companies from compensating another drugmaker to delay entry of a generic.

Under S. 27, a patent settlement is presumed to be anticompetitive if the ANDA filer receives anything of value and agrees to limit or forego R&D, manufacturing, marketing or sales of the ANDA product for any length of time.

The parties to a patent settlement would be exempt from the presumption only if they could demonstrate the competitive benefits of the agreement outweigh its anticompetitive effects.

Earlier this month, the Congressional Budget Office revised its estimates of how much S. 27 could save the government. Its latest projections are that ending pay-for-delay settlements could save $4.8 billion over the next decade.

The Generic Pharmaceutical Association (GPhA) took issue with that estimate, saying it's based on faulty assumptions. One of those assumptions is that brand drugmakers would lose every patent challenge, so generics would come to market faster than they would under a pay-for-delay settlement.

The reality is that generic companies win patent challenges less than half of the time they're pursued, according to the trade group.

The CBO estimate also relies on data provided by the Federal Trade Commission, one of the leading proponents for a ban on the settlements, while ignoring data from independent economists that show such a ban would actually delay generic entry, GPhA said.

The Senate Judiciary Committee passed S. 27 in July, and it has been placed on the Senate calendar for a full vote. (See BioWorld Today, July 25, 2011 .)

S. 1882 co-sponsored by Sens. David Vitter (R-La.), Sherrod Brown (D-Ohio) and Jeff Merkley (D-Ore.) has been referred to the Senate Health, Education, Labor and Pensions Committee.

Push for Ban Leads to Calls for Investigation

The Federal Trade Commission (FTC) has pursued pay-for-delay settlements so much that its chairman, Jon Leibowitz, has come under fire for advocating for a ban on the agreements.

This week, Americans for Limited Government requested that the FTC Office of Inspector General (OIG) investigate whether Leibowitz's actions violate a federal law that prohibits agencies from lobbying Congress.

In a lengthy letter to the OIG, the citizens group pointed out several instances over the past six years in which Leibowitz testified before congressional committees, urging support of a pay-for-delay ban. Additionally, the letter included excerpts from interviews and editorials Leibowitz has written on the subject.

The group also asked for an investigation into a consultancy between the FTC and C. Scott Hemphill, a professor at the Columbia University Law School who has written and testified frequently about the need to end pay-for-delay settlements.

Leibowitz, a former lawyer for the Senate Judiciary Committee, has been nominated for a second term at the FTC. In a Senate confirmation hearing Tuesday, he reiterated his commitment to ending the "sweetheart" pay-for-delay deals, calling them "an especially egregious practice."

Pfizer Looks to End FCPA Probe

Pfizer Inc. has reached agreements, in principle, with the SEC and the Department of Justice to resolve investigations into possible Foreign Corrupt Practices Act (FCPA) violations.

In its quarterly report recently filed with the SEC, Pfizer disclosed that it has provided the government agencies with information about potentially improper payments made by some Pfizer and Wyeth subsidiaries in connection with sales activities outside the U.S. The company expects to enter a final agreement in the fourth quarter.

Meanwhile, authorities in other countries are investigating potentially improper payments and other matters, the company said. Those investigations include civil and criminal probes in Germany into tax matters involving a Pfizer subsidiary.

The company also is under investigation in the U.S. regarding Wyeth's promotional practices and pricing of Protonix (pantoprazole sodium) for Medicaid rebate purposes and off-label promotion of Rapamune (sirolimus). The investigations stem from whistleblower suits.

As the result of another whistleblower action, the New York-based company agreed last month to pay $14.5 million to settle False Claims Act charges related to the off-label marketing of Detrol (tolterodine). (See BioWorld Today, Oct. 24, 2011.)

At the time, Pfizer said that settlement resolved the last of 10 whistleblower suits filed against it, beginning in 2003. The other nine suits were settled or dismissed two years ago as part of a $2.3 billion settlement. Pfizer acquired Wyeth in 2006. (See BioWorld Today, Oct. 14, 2008.)

 
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