Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research. The aim of comparative effectiveness studies is to provide healthcare providers with information about which medical therapies and devices are most effective for patients with a specific health problem. This research goes beyond current requirements that particular treatments be proven to be safe and effective-comparative effectiveness asks whether a particular treatment is also 

  Pharmaceutical companies have expressed concern that the information may lead insurance companies or the government to deny coverage of more expensive treatments. Some experts, including Helen Evans who recently published a 

 with the Heritage Foundation, believe that the government should have not have a major role in comparative effectiveness research or the distribution of its findings. Evans, for example, argues that the private sector should be the primary conductor of comparative effectiveness studies, using the United Kingdom’s system as an example. Many have questioned the UK program’s lack of transparency and “rationing” of healthcare regarding its decisions about drug and treatment coverage. The fact that the program is run under the government-managed healthcare system only adds to the problem.

  The US legislation includes supplemental appropriations for fiscal year 2009 to the Department of Health and Human Services (HHS) to carry out the bill’s plans. Funds are specifically designated to the National Institutes of Health and to the Agency for Healthcare Research and Quality. The bill calls for comparative effectiveness efforts that “conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions” and that “encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.”

  The bill requests that $1.5 million to go toward a contract with the Institute of Medicine to produce and submit a report to Congress and the HHS Secretary by June 30, 2009, that “includes recommendations on the national priorities for comparative effectiveness research to be conducted or supported with the funds provided…and that considers input from stakeholders.” The bill asks the HHS Secretary to consider recommendations from the report and from the soon-to-be-established 15-member Federal Coordinating Council for Comparative Effectiveness Research.

  The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a 

 last week in support of comparative effectiveness research funding and the legislation’s revised language, which supports “patient access and the ability of doctors and patients to choose the treatment that's best for each patient.” PhRMA also noted that it expects the new initiative to be carried out with “real transparency, openness, accountability, and public input in how research priorities are set and how studies are ultimately communicated and conducted.”

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Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research.

Stimulus Bill Opens Door to Comparative Effectiveness

The US Food and Drug Administration withdrew this week its direct 

 on Reporting Information About Authorized Generic Drugs. Originally issued in September 2008 and scheduled to go into effect this week (Feb. 11, 2009), the rule was set to require drugmakers to report information on authorized generics in their annual new drug application (NDA) reports going back to 1999. The rule was part of the FDA Amendments Act (FDAAA).

As part of the September 2007 FDAAA, the agency must publish on its website a list of all authorized generic drugs included in manufacturers’ annual reports. FDA also must update the list every quarter and notify relevant federal agencies, including the Federal Trade Commission, that the list has been published.  

 Under FDA’s direct final rules procedures, the receipt of any significant adverse comment will result in the withdrawal of the direct final rule, according to a written statement from the agency’s Associate Commissioner for Policy and Planning. Comments received will be considered in developing a final rule.

The US Food and Drug Administration withdrew this week its direct final rule on Reporting Information About Authorized Generic Drugs.

Final Rule for Generic Reporting Withdrawn

Taro Pharmaceuticals received a warning letter from the US Food and Drug Administration last week regarding its Brampton, Ontario, Canada manufacturing facility. The agency noted several current good manufacturing practice (GMP) deviations in the manufacture of nonsterile cream and ointment finished drug products. 

FDA inspected the Canadian facility in July 2008. Specifically, three lots of a total 24 lots of fluocinonide cream failed the abbreviated new drug application limit of 6% for the relative standard deviation of assays for tube uniformity stability at 18- and 36-month time stations. Five lots of betamethasone valerate cream failed to meet established purity specifications at the 36- and 48-month time points for purity testing. Two of the three validation lots of ciclopirox olamine cream failed relative standard deviation specification limits for tube-content uniformity at 12-, 18-, and 24-month stability time points. And 11 lots of mupirocin ointment were assigned reduced expiration dates without adequate justification.

The Warning Letter says that Taro’s Sept. 26, 2008 response letter did not address written statements made by the FDA inspector. The agency also notes that out-of-specification results were not thoroughly investigated or performed in a timely manner.

Overall, the “quality control unit failed its responsibility to reject drug products that did not meet specifications,” says the letter.

The letter alludes to the fact that Taro may not be able to continue to ship its products to the US until compliance is ensured. 

Taro Pharmaceuticals received a warning letter from the US Food and Drug Administration last week regarding its Brampton, Ontario, manufacturing facility.

Taro's Ontario Facility Cited for GMP Violations

The US Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration. In a press release issued Feb. 2, 2009, USP said that chief executive officer Roger L. Williams sent letters to Tom Daschle, President Obama’s original choice to lead HHS (see 

), and Frank Torti, the  acting commissioner of FDA. The letters outlined the areas in which USP could “offer scientific support and expertise as the new administration explores ways to better secure the nation’s supplies of medicines and foods.”

The letters cited recent contamination issues such as the heparin and melamine incidents of 2008 and noted that the “need for rigorous standards and practices is more urgent than ever,” according to the release. The letter to  Torti specifically mentioned USP’s expertise in measurement science and how it could apply to FDA’s quality-by-design initiative.  The letter to Williams discussed the goal of compendial harmonization.

Under the 1938 Food, Drug, and Cosmetic Act, all prescription and over-the-counter drugs sold in the US must comply with quality standards published in USP’s book of standards, the 

The United States Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration.

USP Offers HHS Advice and Assistance

Former Senate Majority Leader Tom Daschle withdrew his name from consideration for US Secretary of Health and Human Services (HHS).

“But if 30 years of exposure to the challenges inherent in our system has taught me anything, it has taught me that this work will require a leader who can operate with the full faith of Congress and the American people, and without distraction…. Right now, I am not that leader, and will not be a distraction,” he said in a written statement.

 Nominated by President Obama in early December, Daschle has been clouded by negative press after it was reported that he owed more than $140,000 in back taxes and interest for the years 2005-2007. Daschle has now paid the owed taxes, but many questioned his credibility and also raised ethical concerns over the reported sizeable income he’s received from healthcare groups since leaving the Senate in 2004.

 “I will not be the architect of America’s health system reform, but I remain one of its most fervent supporters,” said Daschle in his statement.

 It is now up to President Obama to select another nominee to head HHS.

HHS Still Without a Leader

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals. The exam is meant to certify intermediate-to-advanced pharmaceutical industry professionals with at least five years experience interpreting and practicing GMP compliance.

Professionals in the following pharmaceutical areas may be interested in taking the exam: change control, engineering and maintenance, GMP-relevant research and development, operations, quality control, quality assurance, compliance, auditing, supply chain management, validation, and technology transfer.

The key benefits of obtaining the certification, according to Robert Seltzer, founder of the new exam and GMP compliance manager at Schering-Plough (Berkeley Heights, NJ), are:  

To enable companies to raise their GMP-compliance “bar” to a higher level 

To support internal company programs of continuous quality improvement 

To have sector-specific applied knowledge

To enhance a professional’s credibility and standing with outside business partners.

Although regulatory bodies such as the US Food and Drug Administration do not officially endorse industry-based certification or training programs, says Seltzer, a number of groups now offer them. The International Society for Pharmaceutical Engineers (ISPE), PTi International, the Center for Professional Education and Innovation, and the New Jersey Pharmaceutical Quality Control Association, for example, all offer GMP certification programs for professionals of varying levels of experience.

The first official ASQ GMP-professional exam will be given in December but several pilot exams will be offered this spring and summer. The exam fee is $230 for ASQ members and $390 for nonmembers. The exam application is online 

and a reference list of suggested study documents are online as well:  

http://www.asq.org/certification/pharmaceutical-gmp/bok.html

http://www.asq.org/certification/pharmaceutical-gmp/references.html

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals.