Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

 issued a draft guidance to clarify the agency’s intentions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and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

Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff

 was created in response to questions FDA has received about which documents and information should include the certification form. FDA states in the draft guidance that the agency “believe(s) that it would not further the purposes of the legislation if a certification were to accompany every type of information or document submitted to the agency regarding a medical product regulated by FDA.” The guidance goes on to state “FDA recommends that a certification typically need not accompany the types of submissions of information or documents to the agency listed below:

Chemistry      and manufacturing amendments to investigational new drug applications      (INDs)

Nonclinical      pharmacology/toxicology amendments to INDs

Investigational      device exemption applications (IDEs)

Marketing and post-marketing applications/submissions

Chemistry      and manufacturing amendments and supplements to biologics license      applications (BLAs) and new drug applications (NDAs)

Nonclinical      pharmacology/toxicology amendments and supplements to BLAs and NDAs

Humanitarian      device exemptions (HDEs) and premarket approval application (PMA) 30 day      notices

ANDA      amendments and supplements that contain no 

ANDA,      BLA, and NDA promotional materials

ANDA,      BLA, NDA, HDE, and PMA mandatory and voluntary adverse event or medical      device reports

510(k)s      that contain no clinical data.”

Articles

The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and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.

FDA Clarifies Certification Requirement

-The US Food and Drug Administration appointed Frank M. Torti, MD, MPH, as principal deputy commissioner and chief scientist. Torti’s appointment with FDA will begin in May. 

The position of chief scientist is a new post created as a part of the Food and Drug Administration Amendments Act of 2007 and is designed to “ensure the quality and regulatory focus of the intramural research programs of the agency and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA’s regulatory structure,” the agency said in a press release. 

Torti has a background in molecular oncology and is chair of the Department of Cancer Biology and director of the Comprehensive Cancer Center at Wake Forest University School of Medicine.  Torti received his medical degree from Harvard Medical School and his Master of Public Health from Harvard School of Public Health.  Torti has served on several health and medical committees. FDA Commissioner Andrew C. von Eschenbach, stated “Dr. Torti’s impressive clinical and scientific credentials are an excellent match for the work we do on a daily basis to promote and protect the nation’s health as a science-based and science-led agency,” in a press release. 

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.

FDA Appoints New Chief Scientist

—In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year drug safety plan under the Prescription Drug User Fee Act (PDUFA). The plan expands from previous years' commitments to accelerate the drug evaluation process to expanding post-market safety evaluations and prevention. With the drug safety plan, FDA intends to reduce medication errors, increase staff, improve existing tools, develop new tools, gain access to new databases, and adopt new standard operating procedures.   

  Included in the draft [deleted PDUFA] are FDA's plans to evaluate current adverse event collection and to develop new reporting software and collection practices. FDA states that it is committed to identifying epidemiology best practices and will produce a new guidance to be finalized in FY 2011. The development and validation of risk management and risk communication tools are also planned. An evaluation and eventual upgrade of FDA's review of new drug trade names will be performed.

  In an effort to increase resources, FDA intends to hire new staff and obtain access to databases that will enable increased post-marketing surveillance and epidemiology. Staff hires will include safety evaluators, risk management experts, medication error experts, and regulatory project managers. The Center for Drug Evaluation and Research (CDER) will expand the Office of Surveillance and Epidemiology (OSE) with new staff "distributed across the office, strengthening the capability and capacity of the organization in its post-marketing safety role." The Center for Biologics Evaluation and Research (CBER) will also increase its staff.

  Under PDUFA IV, drug safety has an annual allocated budget of $29.29 million for FY 2008 that will increase each year with annual inflation. FDA has also been authorized by Congress to collect additional user fees to supplement the program's budget. FDA plans to increase user fee revenues from FY 2008 to FY 2012 in post-market activities from $13 million to $16 million; $7 million to $9.5 million in epidemiology best practices and new data acquisition; risk management and risk communication will increase from $4 million in to $5 million; and new drug trade name review will increase from $5.3 million to $6.5 million.

  FDA's draft of PDUFA IV Drug Safety Five-Year Plan is available for download

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).

FDA's Drug Safety Plan to Increase Post-Market Safety

The deadline for the implementation of California’s prescription drug tracking system, ePedigree, has been delayed until January 2011. Stating that some industry manufacturers and distributors were having a difficult time coming up to speed on implementation requirements by the original January 2009 deadline, the California State Board of Pharmacy decided on March 25 to postpone the deadline for two years. 

The delayed implementation comes after drug manufacturers expressed concerns about standardization issues as well as the complex regulation involved, changes to packaging, and the cost of implementation. The State Board of Pharmacy acknowledged in its ruling that while some companies have been moving forward with the program at a good pace, others have lagged behind. “This board recognizes that this sort of comprehensive model is not easily implemented and that it has required and will require significant efforts by industry participants. After consideration of all the evidence presented to the Board…the Board concurs that the additional two years to January 1, 2011 is [required…] in order to implement electronic technologies to track the distribution of dangerous drugs within the state,” stated William Powers, president of the California State Board of Pharmacy. The board also stated that the delay would give it time to work with FDA to develop standards consistent with Federal guidelines.

The ePedigree system is a part of California’s ongoing effort to combat counterfeit drugs and ensure drug safety. California legislation requires an electronic system be developed to track and trace prescription drugs from manufacture to pharmacy. This tracking system would follow a drug’s path along the distribution line including updates to records if and when a drug moved from one pharmacy chain to another. Information obtained would include prescription name, manufacturer name, dose, container size, lot or control number, purchaser names and addresses, sale dates, and shipping information.

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

California's ePedigree Delayed

Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials. In a March 7 press release, Lilly’s president and chief operating officer John Lechleiter stated that the decision was due to an uncertain regulatory environment, saying, “Without the prospect of a new drug application, keeping the patient foremost in mind, it would not be consistent with our medical principles to continue the clinical trials.”

Quelling concerns of patients involved in the clinical trials, Lilly stressed its decision was not based on product safety. Lechleiter reassured that “patients currently receiving AIR Insulin in our ongoing clinical trials should have no health or safety concerns about continuing to use AIR Insulin during their transition to other well-established diabetes therapies.” Lilly’s executive vice-president of science and technology, Steven M. Paul, reaffirmed that “our decision is not due to any safety concerns observed by Lilly or raised by the independent data safety monitoring board.” Lilly plans on implementing a patient assistance program to provide trial patients in the US with financial support to help fund medications and diagnostic supplies through the end of 2008. Paul says Lilly “remains committed to our mission to develop innovative, beneficial, and cost-effective treatments for diabetic patients.” 

AIR was a joint project between Lilly and Alkermes. In a statement released on March 7, Alkermes stated that Lilly was within its rights to terminate its license to AIR Insulin but that Alkermes believes Phase III safety and efficacy trials should be completed to provide patients, physicians, and scientists with more information on inhaled insulin and other diabetes medications.

While Lilly, Pfizer, and other companies have discontinued similar products, MannKind, which is developing its own version of inhaled insulin, issued a statement on March 10 that it was committed to developing its product and believes that its “small, patient-friendly ‘Medtone’ inhaler delivers ‘Technosphere Insulin’ to patients with diabetes in a way that much more closely matches the pattern of insulin secretion seen in people without disease.”

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

Eli Lilly Terminates AIR Insulin Program

The US Food and Drug Administration recently revealed that the active ingredient used in the production of 

’s recalled drug Heparin was made in a plant in China. FDA and Baxter are both stating that it is not known at this date what role the ingredient may or may not have played in the approximately 350 adverse reactions and four deaths possibly caused by the blood thinner. 

The involvement of a Chinese factory in the production of a recalled drug raises the continued concern regarding Chinese-made products. According to the 

, China is the “world’s largest producer of active pharmaceutical ingredients.” The 

 states that FDA is not required by law to inspect foreign manufacturing facilities but makes it a general rule to do so. FDA admitted it had not inspected the particular Chinese plant due to a mistake in paper work, but plans for the inspection of the plant are under way. The agency has requested that the facility provide inspectional data and adverse event reports regarding the possibly tainted drug. Critics say that the failure of FDA to inspect foreign manufacturing facilities continues to put consumers and patients at risk. 

 that the company has had a 20-year relationship with the supplier and that the supplier has made the specific active ingredient for 30 years. According to the spokesperson, no changes were recently made at the Chinese plant and it is unsure if there is any connection between the plant and the adverse drug effects.

Baxter temporarily halted production of heparin last week due to reports of four patient deaths and allergic reactions that included stomach pain, vomiting, low blood pressure, fast heart rate, and fainting. Baxter is a major producer of heparin, providing half of the nation’s supply. 

(Schaumburg, Illinois) acquires the active ingredient for their heparin blood thinner from a Chinese plant as well but has, reportedly, not experienced the same kinds of adverse effects.

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.