It will be anything but business as usual when Congress reconvenes on Sept. 9, as the debate on military action in Syria is expected to compress the congressional schedule prior to Oct. 1, leading to uncertainty about budget sequestration, funding for health care and research spending. Health-related business, including adjustments to replace sequestration spending cuts for federal agencies, a continuing resolution and an effort to defund the health care overhaul, will take a back seat to the proposed military action.
House Democrats had been gearing up to put an end to budget cuts under sequestration during negotiations in September on a continuing resolution. Meanwhile, some Republicans are determined that they will vote only for a continuing resolution that blocks the health care overhaul.
That agenda was expected to potentially upset plans for the chamber to be out of session the week of Sept. 23, to allow more time to pass the resolution. The debate over military action in Syria will not halt planning for the Oct. 1 start of enrollment for health insurance exchanges or change upcoming deadlines to renew fiscal 2014 federal spend and an extension of federal debt limit levels.
Federal agencies are increasingly feeling the pinch from sequestration, and looking to congressional action for relief.
Because of sequestration, the FDA can’t touch nearly $83 million raised by 2013 user fees until Congress appropriates the funds. For now, the money remains on deposit in the U.S. Treasury. (See BioWorld Today, May 21, 2013.)
Although sequestration was enacted to force Congress to balance the budget, the sequestered FDA fees can’t, by law, be used for any other purpose, including to pay down the deficit. Legislation is pending in the House and Senate to exempt future FDA user fees from sequestration.
The National Institutes of Health (NIH) launched a campaign to raise awareness of the consequences of budget sequestration on its ability to fund grants. The NIH expects to lose $1.6 billion from its 2013 fiscal year budget because of the sequester, translating to a loss of hundreds of grants the agency would otherwise have made. (See BioWorld Today, Aug. 12, 2013.)
The Patent and Trademark Office will see its backlog of new applications growing again, due to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it to continue growing because of the mandatory cuts in fee revenue.
In other news:
• Attorneys Frank J. Sasinowski and Alexander J. Varond, of the firm Hyman, Phelps and McNamara, published an analysis of the FDA’s proposed accelerated marketing approval plan in a comment to the agency’s draft guidance, “Evidentiary Criteria for Accelerated Approval.” The analysis examined each of the 19 “Subpart H” approvals (not for AIDS or cancer) to determine the types and patterns of evidence the FDA has accepted. The authors concluded that the FDA has shown great flexibility in applying Subpart H standards to therapies it is reviewing.
• A District Court judge has ordered hundreds of lawsuits over injuries allegedly caused by Fosamax (alendronate) to be dispersed to courts across the country, rather than settled in a mass court case before a single judge. Approximately 200 cases per month will be sent back to courts where they were initially filed, beginning with the oldest cases. The decision could be costly for Whitehouse Station, N.J.-based Merck & Co. Inc., which markets Fosamax.
• A judge in District Court upheld an Alameda County, Calif., ordinance requiring manufacturers of prescription drugs sold or distributed in the county to fund and operate product stewardship programs allowing consumers to turn in unused medicines rather than flushing them into the water supply. Failure to comply carries a fine of up to $1,000 per day. The Pharmaceutical Research and Manufacturers of America, Generic Pharmaceutical Association and Biotechnology Industry Organization filed suit claiming that the ordinance violates the commerce clause of the constitution. The court found that the ordinance did not discriminate against out-of-state companies or place an impermissible burden on interstate commerce.
• A class action lawsuit was filed in California state court against Fresenius SE and Co. KGaA, of Bad Homburg, Germany, claiming that the company intentionally hid serious risks associated with GranuFlo, a drug it markets for dialysis. The suit alleges that GranuFlo dry powder concentrate greatly increases the risk of stroke and cardiac events, and that Fresenius has been marketing the product for daily dialysis treatment with knowledge of those risks. The product has been on the market since 2003, but was subject to a Class I recall in 2012 by the FDA.
• In a letter addressed to Guido Rasi, executive director of the European Medicines Association (EMA), the Cochrane Collaboration urged the agency to continue its new openness policy in spite of current lawsuits. The group said it has for more than a year received clinical study reports and protocols from the EMA for duloxetine, an antidepressant marketed by Indianapolis-based Eli Lilly and Co., and that those have been very valuable for its research, being more comprehensive and less biased than what Lilly has published in the medical journals. Legal proceedings, which do not involve duloxetine or Lilly, but two other companies, Abbvie Inc. and Intermune Inc., have raised questions regarding whether disclosure of those types of documents might undermine the commercial interests of a natural or legal person under the law.