Generic News

Published Online: Wednesday, February 15, 2012
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Pfizer Continues to Fight the Patent Cliff Slump

Although Lipitor (atorvastatin) lost its coveted patent protection on November 30, 2011, Pfizer has been aggressively launching new strategies to retain some of the revenue the blockbuster drug is losing to cheaper generic alternatives. Under its campaign, Pfizer is targeting patients, insurance companies, and even pharmacists in order to salvage sales of its cholesterol medication, which was once the best-selling prescription drug of all time.

Pfizer is attempting to keep patients on their branded version of Lipitor by offering deep discounts for patients— including $4 copays for a month’s supply of Lipitor—that are cheaper than what the patients would pay for most generic equivalents. Through this program, called the Lipitor For You program, Pfizer will pay up to $50 to account for the difference between the reduced $4 copay and the patient’s usual copay cost. Additionally, Pfizer has agreed to pay rebates to pharmacy benefit managers (PBMs) and insurers if they “eliminate the cost advantage of atorvastatin,” one of Lipitor’s generic competitors. In return, the insurance companies agreeing to this deal with Pfizer must only offer Lipitor as a drug therapy option, effectively limiting competitors’ patient access. Pfizer anticipated that insurance companies would require policy holders to switch to the cheaper generic versions of Lipitor as a cost-saving measure.

The 2 currently available versions of generic atorvastatin will not be the only ones in the game for long: additional generic competitors will be allowed to enter the market starting in June 2012. At that point, analysts say the price for atorvastatin will drop even lower, and Pfizer may not be able to offer Lipitor at a discounted price and still make a profit.

“It’s clear that every company’s watching to see if this works,” Michael Kleinrock, research director at the IMS Institute for Healthcare Informatics, told The Associated Press. He noted that drug makers have come to expect a significant drop in sales when their patents are due to expire, and Pfizer is the first company to try to curb brand abandonment at all levels of the drug hierarchy.

FDA Introduces User Fee Programs

The FDA recommended in January 2012 to institute user fees for generic drugs in order to adequately address the backlog of nearly 900 generic drug applications that are filed each year. Under this proposed agreement, the FDA would charge user fees for abbreviated new drug applications and take these monies to hire extra staff to review these applications. In return, the FDA would have an obligation to drug companies to review a certain percentage of applications within a given time period.

According to the FDA’s news release, the user fees charged would help push generic applications through the pipeline at an accelerated rate, and ensure consumers “timely access to safe, high-quality and effective generic drugs.” This Generic Drug User Fee program would start in 2013, and would be modeled after the Prescription Drug User Fee Act (PDUFA), which has already been reauthorized by lawmakers for three 5-year extensions. The PDUFA allowed for the hire of hundreds of scientists in return for certain performance goals, and the proposed generic user fees would specifically cater to the surge in generic drug developments and the numerous patent expirations that are slated to occur.

The agency also seeks to secure additional funds to hire researchers to test biosimilars under the Biosimilar and Interchangable Products User Fee program. The FDA has only had the authority to review and approve biosimilars since 2010, and biosimilars are more complex and expensive than generic products to evaluate. The user fees for the medical device industry will be the next agreement to be completed.

“These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal,” said Margaret A. Hamburg, MD, FDA commissioner. “At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that the FDA has the resources needed to conduct reviews in a timely fashion.” PT



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