Generic News

Generic Lipitor Off to a Rocky Start

The much-anticipated launch of generic Lipitor was met with pushback from Pfizer in December, when the drug maker followed through on a plan to offer discounts to pharmacy benefit managers (PBMs) in exchange for their promise to exclude generic atorvastatin from their formularies. Now the tactic is being scrutinized by lawmakers, who say it thwarts generic competition and may contribute to excess health costs for consumers and the Medicare program. US Senators Max Baucus (D, MT), Herb Kohl (D, WI), and Chuck Grassley (R, IA) are asking Pfizer and PBMs involved in the deals to cooperate with an investigation into the matter.

“We are concerned that arrangements like this will hinder access to generic drugs,” the senators wrote in a letter addressed to Pfizer, Medco, Express Scripts, Catalyst Rx, UnitedHealth, and Coventry Health Care. “Without the prospect of true competition, generic drug manufacturers will be hesitant to invest the time and resources required to bring lowcost generic drugs to the market.”

The letter was prompted by a November 2011 article in the New York Times that suggested PBMs—not consumers— would pocket the discounts Pfizer provided. The report cited correspondence sent to pharmacies, in which Medco and Catalyst Rx instructed pharmacists to reject all claims for generic atorvastatin and dispense Lipitor in its place.

In an e-mail to Pharmacy Times, Medco said the Times report misrepresented the situation by “quoting sources that are long-time PBM adversaries who provided misleading, inaccurate and incomplete information to create a negative perception.”

Medco says the plan to block generic Lipitor won’t affect 99% of its client health plans or raise costs for patients, who will pay the same amount for the drug whether the generic or brand version is dispensed. The PBM also insists it will not retain any rebate dollars from Pfizer and says it plans to cooperate fully with the senators’ investigation, according to Reuters.

The senators have asked Medco and other companies involved in the deals to provide extensive details about their dealings with Pfizer—from how much of the discount was passed on to consumers to how the agreements were presented in board meetings. It will examine, among other factors, whether Pfizer’s actions constitute an abuse of the Medicare program to boost drug companies’ profits.

“We need to take a close look to ensure we’re protecting both taxpayer dollars and access to the medicine patients need,” said Senator Baucus.

Meanwhile, the tactics are helping Pfizer maintain sales of its topselling drug—at least until May 31, 2012, when more generic versions are expected to flood the market.

GPhA Calls for Collaboration on Drug Shortages

The drug shortage crisis that persisted throughout 2011 won’t be resolved overnight, but experts say it can be minimized through more effective communication between regulators and the generics industry. That’s the idea behind the Accelerated Recovery Initiative (ARI), a new approach developed by the Generic Pharmaceutical Association (GPhA) in December.

Under the proposed solution, an independent third party would gather real-time information about current and future drug supply directly from manufacturers on a voluntary basis. That information would be used to identify and predict shortages that are expected to last longer than 90 days. Critical shortages would be handled by a team within the FDA, helping to bridge the gap between the agency and industry.

Creating channels for collecting, analyzing, and sharing information about shortages would give manufacturers, wholesalers, distributors, and other stakeholders “a better understanding of current conditions” so they can act rapidly, according to Ralph G. Naes, president and chief executive officer of GPhA, who presented the plan to the Senate Committee on Health, Education, Labor, and Pensions.

The initiative is intended to supplement, not replace, the work currently being done by the FDA to reduce drug shortages, he explained. It would also require approval from the Federal Trade Commission and the US Department of Health and Human Services. Whether or not the plan is accepted, collaboration should be the focus of any future effort to address drug shortages, according to GPhA.

“GPhA remains committed to working with all stakeholders to address this crisis,” said Naes. “A lack of supply of a critical drug can be devastating, even if it impacts only 1 patient.” PT