Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

-The US Food and Drug Administration approved 69 new drug applications (NDAs) last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of 

 The data, analyzed by the Friedman, Billings, Ramsey Group (FBR), show that the number of NDAs fell 26% from 93 approvals in 2006, and is 17% below the 10-year average of 83.4.

Included in the 69 NDA approvals were applications to expand a marketed drug’s indication or add a new formulation, according to 

. Also included were two biologics (compared with four in 2006) and 16 new molecular entities (NMEs) such as GlaxoSmithKline’s “Tykerb” (lapatinib) for breast cancer, Merck’s HIV treatment “Istentress” (raltegravir potassium), and Novartis’ hypertension drug “Tekturna” (aliskiren). NME approvals decreased 11% from 2006.

Several media reports have questioned whether  the decline in approvals results from the harsh scrutiny that FDA has endured during the past few years. Approvals-to-submissions ratios have varied from  49%  in 1987 to  109%  in 1996. The 2007 ratio may  be less than 60%, the lowest since 1994, according to 

Another possible reason for the drop in drug approvals may have to do with the current weak pipeline of new drugs. Some claim that industry has, for example, shifted its focus to concentrate on finding new uses for  drugs currently on the market or altering drugs.

“[Companies] got away from their core mission, which was to bring new medicines and new treatments to market,” Kenneth I. Kaitin, director of the Tufts University Center for the Study of Drug Development in Boston, told 

 in a Jan. 8 report. Katitin added that this trend is likely to reverse itself in the next year.

FDA has not yet commented on the FBR report nor confirmed the data.

Articles

The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.

FDA Drug Approvals Reach Record Low

The US Food and Drug Administration’s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee’s findings.

FDA charged the Science Board in March 2006 to review the agency’s “scientific capacities, processes, and infrastructure,” including premarket review and consultation, oversight of product quality, and postmarket product surveillance. FDA also asked the board to provide insight into any agency gaps and to highlight missed opportunities in meeting agency responsibilities. The board created the Subcommittee on Science and Technology, supported by 30 outside experts drawn from industry, academia, and government, to carry out the review.

“The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities,” says the report. In its recommendations, the subcommittee emphasized the need for more FDA funding to address these deficiencies and offered specific suggestions for improvement.

Public comments on the report are due Feb. 3.
  
  

’s article on the subcommittee’s report  

The US Food and Drug Administration?s Subcommittee on Science and Technology released a report in November 2007 announcing that the agency is underfunded and cannot fulfill its mission. The FDA Science Board Advisory Committee has now discussed the report and decided to open a public comment period based on the subcommitee?s findings.

FDA Opens Critical Committee Report to Public Comment

's new PharmTech Talk column. In the year ahead, our editors will be discussing what we hear you discussing such as the statement above. We all attend conferences and workshops, and we all sit quietly and nod our heads as we listen to experts and regulators tell us what we're supposed to be doing to meet standards. But during much-needed coffee breaks, predinner cocktails, and networking receptions, real views tend to come out. It's in those "off-the-record" chats that we hear what you really think about "the state of the industry." 

Take the 2007 American Association of Pharmaceutical Scientists meeting. Despite the numerous, jam-packed quality-by-design and process analytical technology sesssions, I kept hearing disgruntlement from attendees: "Why do we have to change our entire system if FDA is not changing the way it does inspections?" "If we provide FDA with more detailed information, that will open the door to more questions—and perhaps less approvals." "I agree with QbD, but the higher-ups won't pay for it until there are proven results (i.e., revenue)." "Quality systems and harmonization are not required—so why follow them?" 

Another common concern had to do with the global impact on the pharma industry. If a company finalizes its design space, for example, and then decides to contract out a few steps, different regulations in different countries throw a wrench in the whole based, risk managment" plan.  

We'd like to hear your thoughts on these issues, so please email  

 Stay tuned for more PharmTech Talks. Angie Drakulich is the managing editor of 

A few readers commented on this column. Click 

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.

Quality Disconnect

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services (HHS).

Li Changjiang, minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China, and HHS Secretary Mike Leavitt signed two Memoranda of Agreement (MoA) on Dec. 11 in Beijing, just before the third session of the US–China Strategic Economic Dialogue began. The first MoA focuses on food and feed, the second on drugs and medical devices.

“Taken together, these agreements will enhance the safety of scores of household items the American people consume on a daily basis,” said Leavitt.

The agreement has three major components:

To promote information-sharing, all Chinese producers will register with Chinese authorities, who will then share the information with US regulators. In this context, China’s State Food and Drug Administration (SFDA) will inform US authorities if a Chinese facility fails inspection or loses certification, and US Food and Drug Administration officials will gain more access to Chinese production facilities.

To ensure safety, Chinese regulators will certify that food and feed covered by the agreement meets FDA standards. 

To ensure compliance, the Chinese companies will adopt quality-assurance methods (e.g., electronic tracking systems for products).

According to Leavitt, the US will import $2 trillion worth of goods from 825,000 importers in 2008. “To keep up with the pace of global commerce, we need a fundamental shift, from trying to catch unsafe products as they come in, to building quality and safety into products before they reach our borders,” he said.

Leavitt submitted an Action Plan on Import Safety to President George W. Bush in November outlining this new approach, which is supported by the MoA. The plan was part of Leavitt’s work as chair of the Import Safety group, initiated last summer by Bush. 

Chinese and US representatives began work on the MoA during the second session of the US-China Strategic Economic dialogue last May. The dialogue began this time last year to ensure “that citizens of both countries benefit equitably from our growing economic relationship and that we work together to address economic challenges and opportunities,” according to Bush’s statement on the initiative. The dialogue has been overcast by several reports of contaminated “made in China” products, including pet food, toothpaste, juice, and fish, throughout the world. 

The MoA, however, promise to bring “concrete, measurable results” toward alleviating, and fielding off, this problem, said Leavitt.

To read the full US–China agreements, click here: 
  

http://globalhealth.gov/news/agreements/ia121107b.html

http://globalhealth.gov/news/agreements/ia121107a.html

After a negative year in the news, China has finally agreed to improve the safety of its drug and food exports, according to the US Department of Health and Human Services.

China Signs Agreement to Improve Drug and Food Drug Exports

-Tomorrow, Dec. 14, the US Food and Drug Administration’s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine. The meeting is in response to a citizen position that claimed new formulations of OTC cold medications containing phenylephrine HCl (PEH) and phenylephrine bitartrate (PEB) may not actually relieve nasal congestion. 
 
 According to a Dec. 7 announcement from FDA’s Office of Nonprescription Products, a number of studies used to support these OTC medications’ efficacy had problems, such as lack of a placebo arm, small number of subjects, and varying endpoints. Many studies had different designs, populations and outcomes, and several were decades old. Seven of the 14 studies involving 10-mg doses of PEH did not demonstrate a significant effect on nasal decongestion, and the scores were similar for 25-mg doses, said FDA reviewers. 
   
 The citizen petition, led by University of Florida pharmacists and submitted to FDA in February 2007, proposed that the PEH dose increase from 10 mg to 25 mg and the PEB dose increase from 15.6 mg to 40 mg. The petition also called for FDA to require additional studies to demonstrate the drugs’ safety and efficacy in these higher doses. 
 
 Earlier this year, FDA advisory committees recommended that OTC cough and cold medications, including those with phenylephrine, not be used in children under age 6. (See 

)
    
 For the full FDA advisory committee briefings, see 

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

FDA Committee to Tackle Adult OTC Cold Medication Next

As we get ready to head into the new year, chief executive and financial officers may be making their wish lists for 2008. Grow revenue. Increase pipeline. Establish new facility abroad. Acquire small-sized generics company. And so forth. But why not add something "green" to the list?Why not consider ways to help the environment while aiming for success? 

Several companies are already on board. Take Cardinal Health, which is expanding its Dublin, Ohio, headquarters to house the company's Healthcare Supply Chain Services sector. The new facility is up for Leadership in Energy and Environmental Design (LEED)certification—and if approved, will be the first in Dublin to receive the honor. A project of the USGreen Building Council, LEED provides nationally accepted benchmarks for high-performance green buildings. More than 1050buildings in the US, and 1120 worldwide, have been LEED certified, meaning they meet certain sustainable development, water savings, energy efficiency, materials selection, and indoor environmental quality standards. 

On the processing side, Materia (Pasadena, CA) has licensed its metathesis platform to Merck (Whitehouse Station, NJ), Aileron Therapeutics (Cambridge, MA), and Eisai (Tokyo) during the past year. Materia's catalysts help to synthesize potential new drugs with fewer byproducts and less hazardous waste. 

College students are also getting into the green game. With the help of USEnvironmental Protection Agency grants, New Jersey's Rowan University is working with Bristol-Myers Squibb (BMS) (New York) and Novartis (Basel, Switzerland) to develop green engineering designs and practices. The BMS group is specifically looking at a solvent pervaporation project that could reduce carbon dioxide emissions and cut costs.  

So here's to becoming a follower and a leader at the same time. Add "go green"to your comany's list of New Year's resolutions. 

As we get ready to head into the new year, chief executive and financial officers may be making their wish lists for 2008. Grow revenue. Increase pipeline. Establish new facility abroad. Acquire small-sized generics company. And so forth. But why not add something "green" to the list?Why not consider ways to help the environment while aiming for success?