Susan Haigney

The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

FDA highlights success of CDER's drug-monitoring program.

In a presentation published on FDA's website on Mar. 15, 2012, Janet Woodcock, director of CDER, outlined the current status and future plans for FDA's Sentinel Initiative, an electronic drug safety tracking system established as part of the FDA Amendments Act of 2007.

On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama's Oct. 31, 2011 Executive Order.

On Feb. 17, 2012, McNeil Consumer Healthcare, a division of McNeil-PPC, a subsidiary of Johnson & Johnson, voluntarily recalled approximately 574,000 bottles of its OTC pain reliever and fever reducer Infants' Tylenol Oral Suspension, 1 oz. Grape. The voluntary recall was initiated after consumers complained of having difficulty using the SimpleMeasure dosing system.

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.

Arnesto Segredo of Miami, Florida, was sentenced to 70 months in prison for conspiring to divert prescription drugs.

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

Pharmaceutical giants GlaxoSmithKline (GSK) and Pfizer announced on April 16, 2009 that they are joining forces to create a new HIV-focused drug company.

On March 19, 2009, IMS, the leading provider of market research for the pharmaceutical and healthcare industries, reported that annual sales of prescriptions in the US grew 1.3% from 287.6 billion in 2007 to 291.5 billion in 2008.

President Obama nominated Kansas Governor Kathleen Sebelius as his new Secretary of Health and Human Services (HHS).

The US Food and Drug Administration stated its considerations in regards to the three draft annexes to the International Conference on Harmonization's Q4B document.

In a letter to Acting Comptroller General Gene Dodaro dated November 19, 2008, Congressman Joe Barton (R-Texas) requested that the US Government Accountability Office (GAO) review the US Food and Drug Administration's handling of the highly-publicized, tainted heparin scare that occurred in 2007 and 2008.

In an effort to clarify its policy on the use and creation of genetically engineered animals (GE animals), the US Food and Drug Administration released the draft guidance "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" on September 18.

The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories.

The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007.

The California Senate passed SB 1096 on May 29, voting to amend the state?s Confidentiality of Medical Information Act to allow pharmacies to provide third parties with patient information for the purpose of mailing prescription refill reminders and drug information directly to patients.

The devastating May 12 earthquake that struck the Wen Chuan Sichuan province of China left tens of thousands dead, homes and businesses destroyed, and survivors without basic human needs such as shelter, food, and medicines. The quake also had a significant impact on the local industries of the region. Pharmaceutical companies located within the affected areas are assessing possible damage to facilities and loss of personnel.

The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and investigators to complete certification form FDA Form 3674 when submitting documentation to the Agency in order to comply with FDAAA, Title VIII.

The US Food and Drug Administration appointed Frank M. Torti, M.D., M.P.H, as principal deputy commissioner and chief scientist. Torti's appointment with FDA will begin in May.

In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year plan under the Prescription Drug User Fee Act (PDUFA).

The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.

Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials.

The US Food and Drug Administration recently revealed that the active ingredient used in the production of Baxter International Inc.'s recalled drug Heparin was made in a plant in China.

The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter use of "Mevacor" (lovastatin) 20 mg.

Congressmen John Dingell and Bart Stupak have requested that the Government Accountability Office perform an updated assessment report in response to the US Food and Drug Administration?s potential development of a new class of behind-the-counter drugs.