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

Susan Haigney

 October issue) raises that very question.  Earlier this year, the 

 reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.

	This situation is disconcerting on a few levels. First, and most important in my opinion, is the initial problem of a potentially faulty review process that may have allowed unsafe medical devices to reach patients. Second, and certainly a concern for manufacturing companies, is the potential leak by FDA employees of confidential data that had been submitted to FDA with the assurance that it would stay within the agency. And third, is the fact that a government agency may have violated the private correspondence, some of which may be protected under whistleblower laws, of its employees.

	Were the FDA staff members who allegedly leaked confidential company data right for doing what they did? Pharmaceutical companies rely on FDA to protect confidential scientific data that may be crucial to their future business; however, employees should feel safe to express important concerns. Ultimately, it is FDA’s job to protect health. It’s a sticky situation that should be addressed.

	Does FDA need to have a better system in place for employees to voice concerns while also protecting confidential data?

Articles

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

Is FDA putting your company’s confidential data at risk?

	In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of 

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin.

USP Updates Heparin Sodium Monograph

As a result of the passage of the Generic Drug User Fee Amendments Act (GDUFA), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) stated, in a Sept. 7, 2012 memorandum to CDER staff, her plan to reorganize the Office of Generic Drugs (OGD) into a “super office” that would include subordinate offices. The new super Office would report directly to Director Woodcock, with Greg Geba, MD, continuing his role as OGD director.

Another related proposal is to creation of an Office of Pharmaceutical Quality (OPQ) that would oversee quality throughout a drug’s life cycle. This office would take on some of the functions of the Office of Pharmaceutical Science (OPS). Woodcock also proposes aligning some functions of the Office of Manufacturing and Product Quality (OMPQ) into the new OPQ. OMPQ enforcement and compliance functions with remain in the Office of Compliance.

“All of these changes would be part of our ongoing efforts to ensure that CDER’s organizational structure supports our mission to ensure safe, effective, and high-quality drugs for the public," Woodcock stated. "As a regulatory agency, we want the public to be confident that we are successfully dealing with the global economy that is constantly adding more players, more technologies, and more complexity. I believe these organizational changes would give us the foundation we need to meet these new and ever-changing challenges.”

Woodcock stated there would be additional structural changes to come that will “sharpen our focus and bolster our resources around pharmaceutical quality. Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety.”

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

CDER to Expand Office of Generic Drugs

	An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.

	Pharmaceutical companies are eyeing the growing market in India; however, a thriving domestic generics industry is backed by a government wishing to keep the cost of drugs down. Strict Indian patent laws require that an invention be novel, and the government does not recognize patents for drugs they view as being changed slightly in order to extend patent protection. According to Wan, the Indian Patent Office also lacks a searchable patent database, which creates a long patent approval process.

	In a potential game changer, Novartis is asking India’s Supreme Court for patent protection of its cancer drug Glivec. India rejected Novartis’ original patent application six years ago, stating the drug was unpatentable under India’s patent laws because it was a modification of an existing drug. Novartis is challenging India’s ruling.

	It is being speculated that the result of the court case could have significant ramifications for both Western pharmaceutical companies and generic drug makers operating in India. If Novartis wins the battle, it could potentially open the door for other companies that have been denied a patent on the grounds their drug was not novel. According to 

, generic drugs make up approximately 90% of the drug market in India. An increase in patents granted to branded drugs could threaten the Indian generic industry and potentially increase the price of drugs in India.

	What do you think? Are India’s patent laws too strict? If Novartis wins their case in India, will it open the door for other companies to gain patents?

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines.

Borders on Intellectual Property

	PhRMA Senior Vice-President Matthew Bennett released a

 today on the state of the biopharmaceutical industry, in response to an analysis in the 

. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.

	Bennett insists that the US pharmaceutical market has been making advancements in new and novel therapies. According to Bennett, “Last year alone, the Food and Drug Administration approved 35 new molecular entities–the highest amount of approvals over the last decade–including 11 new medicines for patients with rare diseases and Hepatitis C who previously had few or no treatment options.  And earlier this year, the first treatment of its kind was approved for patients suffering from cystic fibrosis, a debilitating disease that affects about 30,000 children and adults in the US.”

	The industry pipeline is healthy with potential novel treatments for Alzheimer’s, Parkinson’s disease, and cancer, according to Bennett, with PhRMA member companies investing “$49.5 billion in 2011 researching and discovering new medicines.”

	Bennett believes the US is on the right track. “The recent passage of the bipartisan Prescription Drug User Fee Act, which will help bring safe, effective, and innovative medicines to patients in a timely manner, is a step in the right direction”, states Bennett.

	Is the US pharmaceutical industry doing enough in biopharmaceutical innovation? Will PDUFA provide the framework for pro-innovation policy?

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal.

PhRMA Defends US Innovation

The European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP) have started to classify all post-authorization measures for human medicines as it phases out follow-up measures to marketing authorizations. The new classification system is being phased in a stepwise manner. Post-authorization measures will be classified as either: conditions in Annex II (obligations or specific obligations to fulfill post-authorization measures); additional pharmacovigilance activities in the risk-management plan; or recommendations for further development.

  EMA and CHMP are reclassifying all outstanding unclassified follow-up measures, starting in August 2012. The first phase of the new classification system tackled initial marketing-authorization-application opinions as of June 2011, followed by post-authorization procedures starting in November 2011.

, “Follow-up measures were measures applied to marketing authorizations, setting out studies and other activities that the Agency and CHMP had asked the marketing-authorization holder to perform.” Affected marketing-authorization holders will receive an outcome fax that includes information about the new classification for each of their applicable products. 

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.