Washington Editor

WASHINGTON - President Barack Obama made a trip to the National Institutes of Health last week to announce the release of $5 billion in stimulus funds for the agency - the single largest ever financial boost to U.S. biomedical research.

The new funds, which are part of the $10.4 billion the agency is receiving under the American Recovery and Reinvestment Act of 2009, are backing more than 12,000 NIH grants, which the president said would create tens of thousands of jobs over the next two years in medical research, manufacturing, supplying medical equipment and building and modernizing laboratories and research facilities. (See BioWorld Today, Feb. 17, 2009, and Aug. 18, 2009.)

Every dollar of research funding produces more than $2 worth of goods and services in the overall U.S. economy, NIH Director Francis Collins said.

The new funds are primarily directed at research in heart disease, autism, HIV-AIDS, the H1N1 swine-origin influenza A virus and cancer.

More than $1 billion of the funding has been set aside for research applying the technology produced by the Human Genome Project, with the intent of finding new cures, officials said.

About $175 million of the stimulus funds have been specifically targeted at the Cancer Genome Atlas - a comprehensive, collaborative effort led by the NIH to map the genomic changes that occur in major types and subtypes of cancer.

TCGA, which spawned from a 2006 pilot project and involves dozens of institutions and about 150 scientists around the U.S., plans to collect more than 20,000 tissue samples from more than 20 cancers over the next five years to determine in detail all of the genetic changes.

"This is an excellent example of how the Recovery Act is fueling discoveries that will fundamentally change the way we fight disease and improve our lives," Collins said.

Senate Panel Adopts Tax Credit Measure

The Senate Finance Committee last week adopted an amendment that would create a tax credit for small biotechs if passed as part of the final health reform legislation.

Under the provision, companies with 250 employees or less would receive reimbursements for a portion of their therapeutic development activities, including hiring scientists and conducting clinical studies.

"Pioneering, research-intensive small businesses would gain critical support through this amendment to continue their cutting-edge projects to develop advanced medicines and, ultimately, cures for the world's most debilitating diseases," Jim Greenwood, CEO of the Biotechnology Industry Organization, said in a statement.

The Finance Committee wrapped up its markup debate early Friday morning. The bill is awaiting a score from the Congressional Budget Office and a vote.

FDA Issues Draft REMS Guide

The FDA last week issued a draft guidance for the industry on risk evaluation and mitigation strategies, which describes regulators' current thinking on the format and content drugmakers should use for their plans.

The FDA has the authority to require a REMS when it determines that it is necessary to ensure that a drug's benefits outweigh its risks. REMS can include medication guides, patient package inserts, communication plans for health care providers, elements to ensure safe use and submission timetables for assessments of the plans.

Drugmakers that violate REMS requirements can be penalized up to $250,000 per violation and up to $10 million maximum.

The FDA last week also issued its strategic plan for communicating risk information to the public and overseeing industry communications.

The plan identifies more than 70 specific actions the FDA plans to take over the next five years, including 14 the agency has committed to accomplishing over the next year.

Allergan Files 'Speech' Suit

Allergan Inc. last week filed a lawsuit against the FDA arguing that the rules prohibiting drugmakers from communicating off-label uses violates First Amendment freedom of speech rights.

Allergan officials told investors and analysts Friday that the government's rules are preventing the Irvine, Calif.-based company from engaging in "robust dialogue" with doctors about "medically accepted" and "commonly prescribed" off-label uses for Botox (onabotulinumtoxinA), such as adult and juvenile spasticity.

Botox was originally approved as an orphan drug for cervical dystonia, a condition characterized by abnormal squeezing and twisting muscle contractions in the head and neck, and blepharospasm, an uncontrolled tic or twitch of the eyelid. But the drug has gone on to be a blockbuster for aesthetic and cosmetic uses.

Allergan officials noted Friday that, paradoxically, the FDA recently required the firm to include in Botox's labeling and risk plan "general" language about certain off-label uses of the drug.

Genetic Data Rules Issued

The U.S. Labor, Treasury and Health and Human Services departments last week issued an interim rule aimed at providing greater protections over genetic information.

The regulations, which were required under the Genetic Information Nondiscrimination Act of 2008, are intended to encourage more genetic testing and ensure genetic data are not used adversely by insurers. The rules forbid health insurers from increasing premiums, denying enrollment or imposing pre-existing-condition exclusions based on the results of genetic information. Insurers also are banned from requesting, requiring or buying genetic information for enrollment purposes. Health plans also cannot ask persons to undergo genetic testing.

FDA Warns New Heparin 10% Less Potent

The FDA last week warned that a change in heparin manufacturing, which was instituted to guard against contamination, has made the reformulated product 10 percent less potent.

Last year, Baxter International Inc. recalled its heparin products after the drugs were linked to numerous U.S. deaths and hundreds of allergic reactions and other adverse events.

The FDA later determined that the drug had been contaminated with oversulfated chondroitin sulfate.

Regulators have asked makers of heparin marketed in the U.S. - Baxter, APP Pharmaceuticals, Hospira Inc. and B. Braun - to identify their reformulated products to differentiate them from the older products.

Heparin also has been involved in several overdose deaths and other adverse events due to labeling mix-ups with Hep-Lock, a weaker blood-thinner used to flush intravenous lines. (See BioWorld Today, May 15, 2008.)

Published: October 5, 2009