Generic Drugs to Market - What's the Climate in 2014?
In This Issue:
- Snapshot of the Agency: FDA-regulated products
- Recent Public Health Milestones
- Innovative Programs at FDA
..A. FDA has a number of programs intended to speed the availability of...more
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more
On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance...more
The first of more than 1,500 Actos cases consolidated in a Louisiana federal court is scheduled to go on trial in January 2014.
The U.S. Judicial Panel on Multidistrict Litigation (MDL) began MDL No. 2299 in December...more
Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...more
On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more
The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more
On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply. The Drug Quality and Security Act (the act) clarifies FDA's authority to regulate drug compounding. It also creates uniform...more
On October 24, 2013, Janet Woodcock, the U.S. Food and Drug Administration’s (“FDA”) Director for the Center for Drug Evaluation and Research (“CDER”),issued a statement explaining that the FDA will recommend that the U.S....more
In the first instance of a district court interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (“Biosimilars Act”), Judge Maxine E. Chesney (N.D. Cal.) dismissed a declaratory...more
Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more
There may be a dangerous, defective or deadly pharmaceutical hiding in your home. Recently, a company named Fresenius Kabi USA initiated a recall of a potentially dangerous lot of magnesium sulfate. Magnesium sulfate is used...more
On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more
As early as 2006, Zoloft was linked to birth defects. Despite clear evidence of dangerous side effects in pregnant women, Pfizer continued to aggressively market the risky drug....more
States have increasingly brought actions under Medicaid fraud or consumer protection statutes seeking civil penalties and restitution from the makers of prescription drugs. Many top-selling drugs have been...more
On September 28, 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (H.R. 3204). The bill is compromise legislation crafted by the Senate Health, Education, Labor, and Pension ("HELP") and House...more
Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more
In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more
Children are not miniature adults, and drugs intended to be consumed by adults aren’t necessarily good medicine for kids. A blog post on the FDA Voice website explains why.
Lynne Yao, associate director, Pediatric and...more
Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more
On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal...more
Paxil (paroxetine) has been available with FDA approval to patients suffering symptoms of depression since 1992. However, in 2005, researchers reported that Paxil could create a risk for birth defects. Their research...more
Taking a page from an established Customs program, importers of active pharmaceutical ingredients (APIs) and finished drug products may now have the opportunity to become eligible for expedited entry into the United States. ...more
Sponsors of developmental new drugs may want to take additional steps to protect their trade secrets and confidential information in the wake of a recent federal court decision narrowly interpreting certain exemptions to the...more
Trends and Analysis:
..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013.
..Among the cases unsealed in July, the government has declined to...more