DID - July 17, 2008 Issue

Vol. 7 No. 139

Congress Rebuffs Bush Medicare Veto, Postponing Drug Price Revision

Congress has overridden President Bush’s veto of a Medicare bill that postpones revisions of the average manufacturer price (AMP) of drugs and includes eprescribing provisions.
 
Bush objected to the Medicare Improvements for Patients and Providers Act of 2008 because it would take away private health plan options from beneficiaries, weaken the Medicare prescription drug program and endanger Medicare’s fiscal security.

Congress disagreed, overriding the veto by a vote of 383–41 in the House and 70–26 in the Senate. The bill was sponsored by Rep. Charles Rangel (D-N.Y.) and introduced in the House June 20.

In his veto message, Bush said some of the provisions in the bill “would enable the expansion of ‘protected classes’ of drugs [that] would effectively end meaningful price negotiations between Medicare prescription drug plans and pharmaceutical manufacturers for drugs in those classes.” This expansion would lead to increased beneficiary premiums and co-payments along with higher drug prices and lower rebates, Bush added. 

Interest Groups, Companies React

Despite Bush’s concerns, interest groups were quick to praise the veto override. The American Pharmacists Association applauded the bill’s requirement for prompt payment of Part D claims and a weekly update of Medicare prescription drug pricing.

Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger also praised the bill, which postpones cuts in the AMP and delays publication of AMP data until Oct. 1, 2009.

“By delaying the AMP provisions, Congress will have time to consider how best to reform the Medicaid pharmacy payment and reporting system to ensure appropriate reimbursement that promotes a level of quality care that all Americans deserve,” Jaeger said.

The bill also includes eprescribing provisions that GPhA supports. “E-prescribing will save lives and save the health care system billions of dollars through reductions in adverse drug events and increased formulary compliance, including higher rates of generic substitution,” Jaeger added.

Zix, a company that hosts services for email encryption and eprescribing, expressed support for the eprescription provision, which will increase Medicare payments beginning in January 2009 to physicians who switch to eprescribing from handwriting prescriptions. In 2011, this incentive begins to decline until it is replaced with a penalty that reduces Medicare payments for physicians who continue handwriting prescriptions. — Elizabeth Jones

 

Gift Ban in Massachusetts Nixed, Prescription Data Restrictions Passed

The Massachusetts House of Representatives stripped a provision from legislation that would have banned gifts from pharmaceutical sales representatives to physicians, and it added restrictions on how firms use prescriber information to the revised bill.

A version of the bill, S. 2660, passed the state Senate earlier this year with a ban on gifts of any value to physicians (DID, April 22).

Instead of banning gifts, the revised bill requires drug firms to adopt a code of conduct and explicitly identifies PhRMA’s code on interaction with healthcare professionals as complying with the law. The trade group recently revised its code (DID, July 11).

Under the House legislation, H. 4974, which passed Wednesday, sales representatives would need to be trained on a code of conduct, and annual audits to monitor compliance would be required. Results of such audits would not have to be submitted to the Department of Public Health.

Drugmakers would be required to adopt policies and procedures for investigating instances of noncompliance and maintain effective lines of communication for employees to report violations. They would have to designate a compliance officer who would be responsible for developing, operating and monitoring the marketing code.

If the bill becomes law, firms would have to submit their codes of conduct to the health department along with descriptions of training programs, descriptions of investigations policies, information on compliance officers and certification that an annual audit was conducted and operations were in compliance.

Restrictions on Prescriber Information

The legislation also would ban the sale and transfer of prescription drug information that identifies either the patient or the prescriber. The bill allows prescription data that do not identify patients or prescribers.

Other prescription data uses permitted by the bill are related to “care management educational communications provided to an individual about the individual’s health condition, adherence to a prescribed course of therapy or other information relating to the drug being dispensed, treatment options or clinical trials,” according to the bill.

IMS Health told DID that the provision on prescription data is similar to legislation enacted by New Hampshire and Maine, both of which were struck down in federal court (DID, Dec. 27, 2007). New Hampshire appealed the ruling, and IMS expects the appeals court to rule on the case soon.

Implementation of the provisions in the bill on prescription information would not take effect until November 2009. The delayed implementation was added pending the outcome of New Hampshire’s appeal. — Christopher Hollis

 

SACHRP Calls for Clarity on When Informed Consent May Be Waived

Guidance is needed to clarify when institutional review boards (IRBs) may allow researchers to waive informed consent, the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) said Wednesday.

Under current federal regulations, IRBs may hesitate to allow waivers or may allow inappropriate waivers, SACHRP’s Subpart A Subcommittee said.

The full committee is advising the HHS Office for Human Research Protections (OHRP) to issue guidance on informed consent waivers, especially for social or behavioral research, that states clearly what documentation is required.

OHRP should consider modifying the requirement that individual subjects be asked whether they want documentation linking them to the research, including the possibility of permitting HHS to waive this requirement on an individual basis, SACHRP said.

The committee said the guidance should clarify that:

  • No links exist between subjects and the research (such as investigator notes) can exist other than in the consent form;
  • Waivers should not be limited to minimal risk research but may be granted, for example, for certain domestic violence studies; and
  • IRBs may grant waivers allowing investigators to address certain elements of consent orally rather than in writing.

OHRP should be given additional resources so it can educate IRBs on the waiver provisions, the committee added.

On a related issue, SACHRP called on OHRP to clarify the role of institutional officials in supervising human research protection programs. OHRP should be given more resources to reach out to these officials and provide them with training and guidance, including periodically sending them reminders about their responsibilities. — Martin Gidron

 

Boehringer Ingelheim Subsidiary Recalls Drug Due to Yeast Contamination

Roxane Laboratories, Boehringer Ingelheim’s generic subsidiary, recalled two lots of sodium polystyrene sulfonate because one lot tested positive for a strain of yeast that could pose a risk of infection, including sepsis, to immunocompromised patients.

The drug is used to treat hyperkalemia, high levels of potassium in blood that can be associated with kidney disease. The two recalled lots consist of approximately 100,000 units, the company told DID.

The product initially passed final testing and met specifications. But the company detected a strain of yeast during final product testing of subsequent production lots, Roxane said.

The firm identified the source of the yeast as a shipment of high-density polyethylene bottles received from a supplier. It then tested two previously released lots, one of which tested positive for the yeast strain. Another lot, which used the same polyethylene bottles, did not test positive for the strain but was recalled as a precaution.

“The company is committed to evaluating and implementing corrective and preventive actions to mitigate future recurrence,” Roxane said. — Christopher Hollis

 

Abbott Sees Strong Quarter Spurred by Humira Sales

Abbott has reported worldwide sales of $7.3 billion for the second quarter, driven in part by sales of its arthritis drug Humira.

The 14.8 percent increase in sales over the second quarter of 2007 was fueled by Humira (adalimumab), which brought in more than $1 billion in the second quarter — a 48.1 percent increase over last year. Abbott projects that Humira could bring in $4.3 billion this year.

In February, Humira was approved as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients age 4 and older (DID, Feb. 25).

The company also saw strong sales of its combination antiretroviral Kaletra (lopinavir/ritonavir), which earned $355 million globally — a 12.7 percent increase over the same quarter last year. In April, the drugmaker received EU approval for the drug’s pediatric formulation (DID, April 8). 

Sales of the epilepsy treatment Depakote (divalproex sodium) also were strong in the second quarter, earning $414 million worldwide. Abbott recently resolved several patent infringement suits over the drug’s extended-release version — one last month with Mylan Pharmaceuticals and two in May with Sandoz and Zydus Pharmaceuticals (DID, June 9).

Abbott also had new products approved this year, including the Xience V drug-eluting stent and the cholesterol drug Simcor, a fixed-dose combination of the firm’s Niaspan (niacin) and simvastatin, the active ingredient in Merck’s Zocor.

“Based on our first-half results, as well as our outlook for the remainder of the year, we’re raising our 2008 forecast for both sales growth and earnings-per-share. We're also confirming our expectation for continued double-digit earnings-per-share growth in 2009,” Miles White, Abbott’s chairman and CEO, said. — Elizabeth Jones

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Reporters: Martin Gidron, April Astor, Christopher Hollis, Elizabeth Jones

President: Cynthia Carter; Publisher: Matt Salt; Editorial Director: David Grant

Copyright © 2008 by Washington Business Information Inc. All rights reserved. Drug Industry Daily (ISSN 1541-6607), an executive briefing on the regulation of pharmaceuticals, is published daily, 250 issues, for $1,495. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permission. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400. For site licenses for multiple users or to purchase multiple copies, contact Content Sales Manager Alka Desai at (703) 538-7669.