FDALegislativeWatch

FDA Legislative Watch Special Update

October 20, 2008

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U.S. FDA Inspections in China

In 2008, foreign manufacturing sites will exceed domestic ones for U.S. FDA-regulated products for the first time.

Digital Mammography Firms Decry Clinical Trial Provisions In Draft Guidance

Digital mammography systems are on the verge of being downclassified to 510(k) status, but imaging firms say the clinical trial requirements proposed in FDA's draft "special controls" guidance for the systems are costly, unnecessary and overly burdensome.

Full-field digital mammography (FFDM) systems capture full digital x-ray images of the breast, and offer an alternative diagnostic and screening tool to conventional film screen mammography.

Medicare Bundling Provisions Could Boost Affymax ESA in ESRD Arena

Affymax sees the end-stage renal disease treatment bundling provisions in the Medicare Improvements for Patients and Providers Act as a potential opportunity for its new erythropoiesis stimulating agent to pull market share from Amgen's Epogen.

"We expect these changes in reimbursement to be disruptive in the overall marketplace and in particular the way Amgen works with the dialysis community," Affymax Chief Commercial Officer Jeffrey Knapp said during an Aug. 28 conference call to discuss the company's updated plans for its developmental ESA Hematide.

The provisions in the law call for CMS to implement a system under Medicare Part B that makes a bundled payment for all products and services related to ESRD treatment, as well as the creation of an ESRD market basket that will be updated annually to reflect changes in the price of an appropriate mix of goods and services.

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.

Sweeping Changes In India’s Clinical Trial Laws Could Allow Phase I MNC Studies Under Certain Circumstances

MUMBAI - Conducting clinical trials in India may get a little easier for multinational drug companies. That is because the much-awaited amendments to the contentious "Schedule Y" of India's Drug and Cosmetics Act have moved one step forward.

Industry sources informed PharmAsia News that the Drug Technical Advisory Board has "in principle" accepted the proposals for sweeping changes in Schedule Y. The act deals with laws that govern clinical trial practices and lays down guidelines for Good Clinical Practices in India.

Physician Payment Disclosure Bill Should Include Other Entities – MedPAC

The Medicare Payment Advisory Commission is recommending a more comprehensive system for reporting pharmaceutical industry payments than the one proposed in legislation pending before Congress.

The Physician Payments Sunshine Act, first introduced in the Senate by Chuck Grassley, R-Iowa, and Herb Kohl, D-Wisc., calls for a publicly available database containing physicians' names, payments made to them by companies and the purpose of those payments

Pregnancy Registries Should Not Be Mandated In Drug Label, Amgen Tells FDA

Industry is challenging one of the central components of FDA's proposed rule on pregnancy and lactation labeling - that any existing registries for patients should be included in labeling.

From FDA's point of view, including information on pregnancy registries in labeling would enable consumers to enroll in such programs and obtain further data.

In comments on the proposed reg, however, Amgen cautions against potential shortfalls of registry data. The firm notes that though such information is "appropriate in most situations ... it is based on the premise that all pregnancy exposure registries are adequately designed and executed, which is not always true."

Marketing Oversight By States Creates Multiple Compliance Standards For Firms

As more and more states pass laws that require pharmaceutical companies to disclose payments to health care practitioners, there needs to be a single definition of which data must be reported, according to John Patrick Oroho, executive vice president of Porzio Pharmaceutical Services.

"It's difficult to track the information in the first place, but it's a lot more difficult when you have different definitions across the country," Oroho said in an interview.

The marketing disclosure bills introduced in nine states during 2008 contain varying reporting thresholds and exemptions, Oroho pointed out during a recent Center for Business Intelligence conference. PPS provides consulting services on federal and state regulations governing pharmaceutical marketing and sales practices.

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.