FDALegislativeWatch

FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site

FDA's quarterly report that lists potential signals of serious risks for drugs is similar in design to a program that the agency proposed and then withdrew following industry criticism.

The new quarterly report, announced and posted on FDA's Web site Sept. 5, is in direct response to a provision in the FDA Amendments Act of 2007.

New Generics Need To Influence Medicare Rates More Quickly – OIG

Health and Human Services' Office of Inspector General is calling on the Centers for Medicare and Medicaid Services to more quickly adjust reimbursement rates for Medicare Part B drugs when low-priced generics enter the market.

In a report released August 27, OIG focused on the payment amount for irinotecan (Pfizer's Camptosar) after the first generic was approved. Based on its calculation that Medicare reimbursed "more than double" the average prices paid in the marketplace, OIG recommended that CMS "explore options to expedite the process to ensure that Medicare payment amounts for drugs with newly available generic versions accurately reflect market prices."

Generic irinotecan was first approved Feb. 20. The following month, the Medicare payment amount was $126.31, and the OIG-calculated average manufacturer sales price - total sales by one brand and six generic manufacturers divided by total number of units sold in March - was $51.59.

FDA Learns By Doing In Using REMS Powers; Guidance In “Future”

FDA decisions on whether to require a risk evaluation and mitigation strategy for a new drug will continue to be made on a case-by-case basis while the agency gains on-the-job experience in interpreting requirements of the FDA Amendments Act.

There is no timeline for developing guidance for industry on what the REMS provisions mean and procedures for implementing them, Office of New Drugs Director John Jenkins explained at a CDER town hall meeting during the Drug Information Association meeting in Boston June 26.

"We're still trying to learn what the process might be, what the triggers are, what the expectations are, so that we can convey those to you in a guidance."

FDA’s Sentinel Safety Surveillance Could Ease Phase IV Study Burden

FDA recognizes its Sentinel post-market safety surveillance project could help answer some questions that typically would be explored in Phase IV studies.

Sentinel is envisioned as a national network of existing electronic data systems - such as electronic health records and medical claims databases - that FDA could access to monitor the safety of drugs and devices (¹"The Pink Sheet," May 26, 2008, p. 3).

During a May 22 conference call on the project, Center for Biologics Evaluation and Research Director Jesse Goodman said, "We can use these kinds of databases, in essence, as part of the Phase IV post-marketing studies" to see whether a signal that emerged pre-licensure "represented something real or not."

Schering's Zetia Promotion to Physicians Draws Inquiry From Senator Kohl

Senate Aging Committee Chairman Herb Kohl, D-Wisc. requests that Schering-Plough provide information on a recent physician-aimed marketing campaign for Zetia (ezetimibe), in a March 13 letter to the firm.

With the inquiry, Kohl turns up the heat on congressional interest in marketing practices for Zetia and Vytorin (ezetimibe/simvastatin) in light of the negative ENHANCE results). The House Energy and Commerce Committee also has sent letters to Schering and Merck on the issue.

Is Faster Better? Senators Question Surrogate Endpoints, Fast Track Status

Several U.S. senators are using congressional inquiry mechanisms to challenge the fundamental underpinnings of rapid FDA drug review.

Ranking Member of the Senate Finance Committee Chuck Grassley, R-Iowa, announced March 4 that he is calling for a Government Accountability Office investigation into how the FDA follows up on the safety and efficacy of drugs approved based on surrogate endpoints.

Safety First: FDA Unveils Postmarketing Management Process for Safety

With FDA's latest new initiatives to address problems with postmarketing safety processes -Safety First/Safe Use - the agency is aiming at applying PDUFA-style management to postmarketing drug safety issues.

The Prescription Drug User Fee Act system for pre-market review is laden with clear objectives, standards and timelines that have become firmly entrenched in FDA's practices. With Safety First, the agency seems to be attempting to impose that sort of order and tracking on the postmarketing side of its activities - an area where FDA is frequently criticized.

FDA/China Import Safety MOU Will Be Signed Mid-December

This article is reprinted from "The Pink Sheet" – December 10, 2007

HHS Secretary Mike Leavitt expects to finalize a memorandum of understanding for drug and medical device safety during his trip to China the week of Dec. 10, but the agreement will not include plans to establish a permanent FDA office in China.

FDA Should Track Inclusion Of Seniors In Clinical Trails More Carefully - GAO

A report by the General Accountability Office concludes that the FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors.

Prepared for Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass., the report finds that about two-thirds of medical officer reviews examined by GAO included a discussion of the safety and effectiveness for elderly patients, and one-quarter of reviews discussed the "sufficiency of representation of elderly persons."

Pharma Awaits Market Impact Of Added FDA Bill Safety Proposals, IMS Says

FDA's safety assessments may serve as the wildcard for how the pharmaceutical market will play out in 2008, IMS says, as the agency evaluates safety priorities and implements additional postmarket review strategies authorized by the FDA Amendments Act.