FDALegislativeWatch

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.

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

At Democratic And Republican Conventions, Pharma Donates Money, Hosts Events

Top executives from the pharmaceutical industry will be hobnobbing with legislators and celebrities at the Democratic National Convention in Denver this week and at the Republican National Convention in St. Paul next week.

CMS Open To ASPs For Radiopharmaceuticals; Congress Blocks Rate Cap

CMS is willing to consider switching Medicare Part B payment for radiopharmaceuticals to the average sales price formula, the agency says in proposed rules to update Medicare's hospital outpatient prospective payment system for 2009.

The agency's expression of flexibility comes just as Congress passed a measure to continue blocking Medicare's payment cap on the products.

In the proposed rules, slated for July 18 publication in the Federal Register, CMS says that for therapeutic radiopharmaceuticals "where ASP information is submitted through the established ASP process by all manufacturers of the specific radiopharmaceutical, we would provide payment for the average acquisition and associated handling costs ... at the same relative ASP-based amount (proposed at ASP+4 percent for CY 2009) that we would pay for separately payable drugs and biologicals in CY 2009 under the OPPS."

The two key drugs likely to be affected by such a change are Cell Therapeutics' Zevalin (ibritumomab tiuxetan) and GlaxoSmithKline's Bexxar (tositumomab). They are among several radiopharmaceuticals that CMS for now wants to pay outside of the ASP formula and make subject to payment caps.

FY 2009 Approps Package Will Likely Need To Wait For Next Administration

House Democratic leaders are signaling an intention to put off finalizing fiscal year 2009 appropriations at least until next March, charging Republican members of Congress and the Bush administration with standing in the way of negotiating mutually agreeable bills.

The move would put in limbo some of the $300-plus million increase in funding proposed for FDA in fiscal 2009, which begins Oct. 1.

This could be a setback for groups - including device and drug industry representatives - that have been lobbying for a significant injection of money into the agency. However, they point to a supplemental 2008 appropriations bill signed by the president June 30 that includes extra FDA money as an important step, regardless of what happens with the 2009 provisions.

California E-Pedigree Phase-In Bill Moving Through State Legislature

A bill is moving through the California legislature that would delay yet again the implementation of the state's electronic pedigree mandate, offering a phased implementation schedule with a requirement that all drugs come into compliance by 2015.

Instead of implementing the state e-pedigree rules by Jan. 1, 2011 - the current deadline set after the latest two-year implementation extension (¹"The Pink Sheet," March 31, 2008, p. 20) - the new proposal sets a phased-in approach under which manufacturers self-select 20 percent of their product line to meet e-pedigree requirements by 2011, 50 percent by 2013 and all products by 2015.

E-Pedigree Could Be A Key Law Enforcement Tool, J&J Exec Says

While much of the discussion surrounding electronic pedigrees and the accompanying track-and-trace technology has been focused on allowing all parts of the supply chain to verify the authenticity of the pharmaceutical products they receive, the data and technology also could be a valuable tool for law enforcement agents.

"Making distributors produce an e-pedigree for law enforcement when products are questioned would increase the effectiveness of law enforcement in combating counterfeiting," Johnson & Johnson VP of Supply Chain Technology Mike Rose said in testimony June 17 before the Senate Judiciary Committee. "Immediate information about the authenticity of a product puts powerful information in the hands of law enforcement for enforcement action."

Medicare Bill Strikes Out Again In Senate After Home Run In House

Momentum from a surprising House passage of a slightly modified version of the Sen. Max Baucus-penned Medicare physician payment legislation was not quite enough to carry the bill on a second try in the Senate on June 26.

Hanging in the balance are a number of pharmaceutical provisions, including incentives to adopt electronic prescribing, delays for the implementation of Medicaid average manufacturer price reimbursement rules, authority for Medicare Part D to cover benzodiazepines and barbiturates, codification of Medicare's six protected classes, and Medicare prompt payment provisions.

The primary focus of the House bill H.R. 6331 and the original Senate bill it was based on, S. 3101, was to halt Medicare physician payment cuts scheduled to go into effect July 1.

Medicare bill brought back to life ... in House

Senate Finance Committee Chairman Max Baucus' Medicare physician payment fix package did not win enough support in the Senate to proceed to a vote but may get a second shot, this time in the House. Ways and Means Committee Chairman Charles Rangel, D-N.Y. introduced H.R. 6331 on June 20, a bill that uses Baucus' failed S. 3101 as its base while making minor adjustments. The only drug-related change Rangel highlighted is that Medicare Part D plans could start covering benzodiazepines and barbiturates in 2013, instead of 2012 as proposed in S. 3101. A vote on the House bill is planned for June 24. This article is reprinted from "The Pink Sheet" – June 24, 2008