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

Susan Haigney

-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 drug products for which updated draft product-specific bioequivalence recommendations are available include: risedronate sodium, fosinopril sodium/hydrochlorothiazide, fluoxetine HCI/olanzapine, erlotinib HCI, and morphine sulfate.

In 2007, FDA announced in its draft guidance for industry, “

Bioequivalence Recommendations for Specific Products

,” that the agency was providing product-specific bioequivalence recommendations on its website to solicit public consideration and recommendations. The online process is intended to support drug manufacturers with abbreviated new drug applications. 

 for the announcement of the new recommendations and 

 for the updated bioequivalence recommendations list.  

Articles

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.

FDA Updates Bioequivalence Guidelines

-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 bill now moves to the California Assembly.

California’s Confidentiality of Medical Information Act prohibits health care providers and health service plans from sharing or selling patient information for marketing or other purposes without the patient’s authorization. SB 1096 would amend that Act to “allow a pharmacy to mail specified written communications to a patient, without the patient’s authorization under specified conditions.” The conditions limit information to prescription label language of only doctor-prescribed medication with instructions to contact a physician if the patient has questions. The mailed communications are prohibited from mentioning other products or medications that have not been prescribed by the patient’s doctor. Medications involved are limited to certain diseases listed in the bill. 

The state senate rejected an earlier version of SB 1096 because it did not give patients a clear enough way to opt out of the program. The bill was revised to include a provision that the pharmacy offer patients the ability to opt out of receiving mailed information at the time the patient picks up their medications. Patients would also have a phone number to call or a Website to visit to stop receiving mailings at a later date.

Supporters of SB 1096, introduced by California State Senator Ron Calderon, suggest that written, mailed information would encourage proper use of prescribed medication. A 

California Senate Health Committee Analysis of the bill

  notes a 2007 study released by the National Council of Patient Information and Education that estimated that only half of patients take their prescribed medication. Another study from the 

 showed that reminding patients to take their medication had positive results. Supporters suggest that improper use of prescribed medication results in millions of dollars in Medicaid costs and drug-related hospitalizations.

However, opponents of the bill, like the Consumer Federation of California (CFC), insist the bill violates patient privacy and may interfere with the doctor-patient relationship. In a letter posted on 

, the CFC stated that the bill “is a significant intervention by drug companies into the physician-patient relationship. We believe a patient’s doctor is the best source for informing a patient about how to manage his or her health condition.” The CFC believes that such mailings might confuse certain patients, especially senior citizens, if they receive contradictory information from what they have been told by their doctor. “This kind of direct interference in the doctor-patient relationship is potentially dangerous to patient health.” According to the CFC, the company sponsoring the legislation, Adheris Inc, may directly benefit from the bill. Passage of the bill could possibly invalidate a 2004 lawsuit filed against Adheris for mailing personalized letters from pharmacies to patients, according to the CFC.

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.

California Senate Passes Bill That Would Amend the State Confidentiality of Medical Information Act

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. And in response to the area’s need for medical supplies, pharma companies inside and outside of China are offering help to the people left devastated by the disaster by providing drugs and medical devices. 

The majority of pharmaceutical plants located in the region have not yet reported any significant structural damage or loss of personnel because of the quake. 

, Inc (Xi’an, China), a developer and producer of plant extracts and pharmaceutical raw materials, announced that there was no damage to their facilities and workers have returned to the operation. “We are terribly saddened by the loss of life and property in the Sichuan Earthquake. While we are happy to report that neither our employees nor our facilities suffered any harm, Huifeng is prepared to provide support to the victims of this terrible disaster,” company CEO Jing’An Wang stated in a company press release. American Oriental Bioengineering also reported no significant impact. “Our thoughts are with the many victims of China’s earthquake and we are thankful to report that none of our staff was hurt in the tragic events. Our manufacturing, production, and overall operations were not impacted by the earthquake and we do not anticipate any damage-related impact to our sales in the second quarter,” stated Tony Lui, chairman and CEO, in a company press release.

However, not every pharmaceutical company came away unaffected. 

, located in Shenzhen, announced on May 14 that the quake damaged the water piping system in its Guiyang facility. The damage compromised the production of the osteoporosis drug Xianling Gubao (XLGB), and the company temporarily halted production.  Xiaochun Wang, Tongjitang’s chief executive office, stated in a company press release, “We are committed to the highest quality levels of production. Currently, we are working diligently to make sure that production will be resumed as soon as conditions allow.”

 has reported that pharmacies in the area have been destroyed, leaving a shortage of medicines. The pharmaceutical industry has responded to the devastation with donations of cash and supplies from nearly all pharmaceutical companies, big and small, across the globe and from companies inside China. According to Interfax China, 

 has donated $3.57 million in drugs and medical devices that include ventilators, electrocardiogram monitors, and IV infusion kits. 

 (Hainan) announced on May 16 that it donated over $280,000 of antibiotics, antivirus, and anti-cold products to the relief effort. 

 (Tustin, CA), donated more than $70,000 in products to the 

. Donations continue to arrive to relief organizations in the region from companies and individuals around the world.

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.

China Earthquake Shakes Up Pharma Do-Gooders

 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.”

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).