Evaluating the Pieces of the Pharma Supply Chain

With low-cost production and a pool of scientific talent, Asia, specifically China and India, has risen in pharmaceutical outsourcing and ingredient supply over the past several years. High-profile events concering product quality and manufacturing practices for select suppliers, and recent political turmoil in India, however, have placed increased attention on the region.

(ILLUSTRATION BY M.MCEVOY. IMAGES: JOHN LAMB, ULTRA.F/GETTY IMAGES)

Key events were the importation of contaminated heparin supplied from a Chinese facility (see sidebar, "Post-Heparin: Baxter Responds") and incidents of melamine in food and pet food products and diethylene glycol in toothpaste from China (1-4). In September 2008, the US Food and Drug Administration issued warning letters and an import alert for products made at two facilities of Ranbaxy Laboratories (Gurgaon, Haryana), one of India's largest pharmaceut ical companies, for deviations in current good manufacturing practices (5). And recent terrorist attacks in Mumbai, India's capital, raised security concerns.

Assessing Asia's role

But before considering these events, it is important to evaluate the fundamentals of pharmaceutical outsourcing to Asia. "Cost has always been a driver of outsourcing decisions," says Mike Keech, director of PricewaterhouseCoopers' (PwC) advisory services group in the pharmaceutical and life-sciences sector. "But in today's market, cost is no longer the primary driver—it's just an additional evaluation point. You have to balance cost with risk and market opportunity. Companies today, for example, are balancing their outsourcing approach by trying to look at technology and intellectual property protection along with development and manufacturing capacity capabilities."

To more fully understand those issues, PwC assessed 13 Asian countries based on cost, risk, and market opportunity, and released the results of that study in October 2008. China and India ranked as the two most desirable outsourcing candidates among Big Pharma (see Figure 1) (6). Keech points out, however, the buyer has become more sophisticated and how much longer China and India hold their top positions remains to be seen.

Figure 1. PricewaterhouseCoopers assessed the risk of outsourcing to the above 13 Asian territories based on three core factors. The factors were weighted as follows: Cost (33% total), which includes compensation and wages (15%), infrastructure (8%), tax and regulatory expenses (10%); General risks (37% total), including geopolitical (6%), human capital (10%), economic (7%), legal (8%), and infrastructure (6%); and Market opportunity (30% total), including healthcare needs of current and future population (15%), market size (7%), and market growth rate (8%). (FIGURE IS COURTESY OF PRICEWATERHOUSE COOPERS, 2008.)

Other Asian countries are gaining a foothold as viable pharmaceutical outsourcing contenders. Korea and Taiwan are just a few steps behind China and India, says Keech, and will soon be followed by Indonesia and Malaysia. Much farther down on the list of ideal outsourcing candidates is Thailand, which "looks interesting from a labor perspective and because of their worldclass set of intellectual property laws," says Keech, but whose "interpretation and enforcement are far from ideal."

Rather than looking at the cost per unit as a measure for a particular product, companies are now evaluating inbound transportation, custom-clearance issues, and additional testing requirements, explains Keech. As they start to look at this "total land-net cost," he says, "companies may choose an outsourcing partner based on the product's stage in the life cycle and the company's overall goals. Is the company simply striving to reduce costs at the end of a product's patent life, for example, or is it looking for more flexible and modern manufacturing, and perhaps unique competencies?"

Even though Western companies can still have a 50–60% savings in manufacturing by outsourcing to Asia, the region "is not as attractive as it used to be," says Keech. "One PwC client, for instance, used to go to Asia alone because it was cost-driven, but given safety issues of late, they're looking at all different outsourcing candidates—especially in Eastern Europe—regardless of geography," says Keech.

Big Pharma's outsourcing to Asia

A consensus among several pharmaceutical majors is that Asia will continue to play a part in their research, drug-development and sourcing activities, but as part of larger corporate goals for cost reduction, broadening use of external partners, and globalization. For example, like other pharmaceutical majors, Pfizer (New York) plans to increase its level of outsourcing as it rationalizes its manufacturing network. In its recent quarterly earnings report (ended Sept. 30, 2008), the company says it expects to increase its level of outsourced manufacturing from a current level of roughly 17% of its products on a cost basis to 30% during the next two to three years.

Figure 2: PricewaterhouseCoopers’ cost ranking of Asianterritories.

Pfizer, however, emphasizes that adherence to quality standards are a prerequisite for working with any supplier. "The importance of a full and complete evaluation of a potential supplier or contract manufacturer by the pharmaceutical firm cannot be overemphasized," said Natale S. Riccardi, president of Pfizer Global Manufacturing and senior vice-president of Pfizer, in a recent interview with Pharmaceutical Technology (7). "A thorough review of the potential partners' quality systems, including verification that they have control over their own supply chain, must be completed to determine whether they are willing and able to meet the required standards. If they are not, access to the supply chain should be denied until they have demonstrated that the required standards are being applied. Once a supplier is approved for use, ongoing quality oversight is critical to ensure that the standards continue to be met. We have done that and in fact, have not approved suppliers that have not demonstrated sufficient progress."

Different Interpretations of Quality

As a larger percentage of active pharmaceutical ingredients (APIs) is outsourced, there is a resulting need to broaden the supply base and gain the knowledge and understanding of the capabilities of external suppliers. To that end, Pfizer established in 2006 a center of excellence team based in Singapore to work in markets in India and China. This team works in concert with the company's strategy to optimize its internal plant network and in planning transitional inventory coverage as external suppliers are qualified (7). For contract R&D, Pfizer also has relationships with contract research organizations in Asia, including WuXi PharmaTech (Shanghai), Chembiotek (Kolkata, India), and HD Biosciences (Shanghai) (8).

To strengthen its global API sourcing, AstraZeneca (London) opened a new sourcing center in China in early 2007, which is in addition to another sourcing center in Bangalore, India. These moves are part of other recent investment in Asia. In 2007, the company opened a $15-million process research and development center in Bangalore to complement its drugdiscovery programs there. The company also is investing $100 million for a new translational science research facility in Shanghai. As part of its supply-chain strategy, in November 2008, the company said it is further investing in its facility in Wuxi, China, to support its growth in Asia Pacific, to provide additional packing and formulation capabilities, and to make Wuxi its packing center for Asia Pacific. AstraZeneca established a manufacturing site in Wuxi in 2001 with an initial invesment of $134 millon and made an additional investment of $35 million in 2006.

Eli Lilly (Indianapolis) is pursuing what it calls its "FIPNet" strategy, which emphasizes the company's role in assembling and managing a network of external partners. This focus is a change from its practice of being what it calls a "FIPCo," or a fully integrated pharmaceutical company that owns everything from idea-generation to sales.

"We're testing new collaborations with life-sciences firms in China and India," said John C. Lechleiter, president and CEO of Eli Lilly in a speech in September 2008 (9). "Lilly scientists still design our compounds, for example, but a large number of our chemistry-based molecules are now synthesized by a firm in Shanghai, called ShangPharma. In India, meanwhile, we've handed off some molecules using new risk-sharing deals. We have the right to buy back these molecules ... once our collaborators succeed in establishing proof of concept in the clinic."

As another example, in October 2008, Lilly agreed to form a drug-development joint venture with the Indian firm Jubilant Organosys (New Delhi), a contract provider of custom research, manufacturing, and drug-discovery services. The joint venture, based in Bangalore, is modeled after Lilly's early-stage development division, Chorus, which provides drug development for Lilly exclusively through external contract companies. The joint venture will focus on preclinical molecules and their development through Phase II clinical testing before returning successful assets to the sponsors for further development.

Figure 3: PricewaterhouseCoopers’ wider risk ranking of Asian countries.

Industry observers say recent events have not altered pharmaceutical companies' interest in doing business in India. "After the heparin incident, I would say that the comfort level of pharmaceutical companies working with India contract manufacturers increased, not decreased, because of greater transparency in India than in China," says Nailesh Bhatt, managing director of the consulting firm Proximare. He points to the smaller size of India, the benefit of having English as a common language with Western companies, a smaller supplier base, and the increased attention on the supply chain as FDA establishes a presence in the country (see sidebar, "Regulators Grow Global Presence"). "The increased supply-chain robustness is a positive development for Indian CMOs," he says.

He also says that the terrorist attacks in Mumbai in late November 2008 are not likely to dissuade pharmaceutical outsourcing. "The new reality of global terrorism shows that any geographic location is not immune to terrorism." In the case of Mumbai, he points out that the attacks were localized in the city and did not occur in surrounding areas outside of Mumbai, where pharmaceutical manufacturing facilities are located, and that manufacturing activities are diffused in various hubs throughout the country such as in New Delhi and Hyderabad. "The immediate effect has been a beefing up of security and consideration of options for business travel."

Figure 4: PricewaterhouseCoopers’ market opportunity ranking of Asian territories.

Although Asia will play a role in pharmaceutical outsourcing, others point to favorable fundamentals for US and Western European suppliers. "As long as the world's innovative pharmaceutical industry is centered in the West, there will be a need for API development and manufacturing capacity in the West," says Brian Scanlan, vice-president of corporate development at Cambridge Major Laboratories (Germantown, WI), a contract manufacturer of APIs and intermediates. "Our view is that most of the new drugs in development are owned by the small, medium, and virtual pharma companies. The future of these companies resides in one or two molecules in development. The vast majority of them are not going to entrust the future of their company to a company on the other side of the world—it just won't happen. Big Pharma is in a very different scenario. They have the ability to offshore some of their pipeline, but the highest profile, most important new APIs are, by and large, still be entrusted to Western-based companies for development."

Securing the supply chain: Leaders at work

Over the course of 2008, regulators, including FDA, US legislators, and other standard-setting bodies made changes and proposals to improve pharmaceutical import and product safety.

Monographs. The US Pharmacopeia (USP) took immediate action to respond to the heparin contamination by revising its heparin sodium and heparin calcium monographs (Stage 2 of the revisions are scheduled to be published in March 2009). "There's a lot of work going on in USP now, even beyond heparin, to tighten up monographs that might be susceptible to contamination," says USP CEO and

Executive Vice-President Roger L. Williams. "We're working more on our USP Glycerin monograph, for example, with regard to diethylene glycol, and on FCC monographs for Wheat Gluten and other food ingredients that are susceptible to melamine adulteration. We want to help outsourcers know they are purchasing good materials if it conforms to a USP monograph on their certificate of analysis."

Legislative proposals. Last April, US Representatives John Dingell (D-MI), Frank Pallone, Jr. (D-NJ), and Bart Stupak (D-MI) issued a discussion draft of the Food and Drug Administration Globalization Act of 2008 to improve the FDA inspection process (10). Revised in July, the discussion draft proposes that:

• All drug facilities operating within the US or exporting products to the US register with FDA annually (a registration fee would generate resources for inspections)

• FDA inspect foreign and domestic facilities every two to four years, provided sufficient information has been given to the agency to assess risk (a manufacturer would not be able introduce a drug or ingredient into the marketplace until an initial facility inspection has been conducted)

• Restrictions be placed on the entry of imports that lack safety documentation

• Drug establishments implement a quality riskmanagement plan

• Manufacturers test and verify drug identity and purity

• FDA issue fines for violations of drug-safety requirements; the agency's authority would be extended to recall and detain dangerous drugs as well as to destroy counterfeit or adulterated imports

• Electronic pedigrees document a drug's supply chain

• Country-of-origin labeling identify the source of APIs and their place of manufacture (11).

Although the Globalization Act is still circulating as a proposal within Congress, FDA Press Officer Christopher C. Kelly says the agency is already tweaking its inspection process to be more global in nature. "We are putting an emphasis on the supply chain during the regular course of our good manufacturing practice inspections and preapproval inspections," he says. "We are looking at sourcing and actively participating in industry conferences and professional forums on the topic as well as attempting to increase our coverage." FDA is opening up several offices abroad and dedicating more inspectors for foreign plants.

The agency is also improving its system for registration of foreign facilities. The FDA Foreign Facility Registration Verification Project is meant to establish a contract relationship with nongovernmental organizations that have an office overseas that can verify, as trusted FDA agents, the registration data of foreign firms that are shipping to the US. "The process will include visiting the foreign firms, verifying, and documenting the existence of the firms, and confirming the firms manufacture the products that FDA import records indicate the firms export to the US," explains Kelly. The project is expected to include, but not be limited to China, India, and Mexico.

Dingell plans to introduce a bill ref lecting the revised discussion draft in the House Energy and Commerce Committee early this year (12). Some industry groups are voicing concerns on certain aspects of the proposed legislation.

The International Pharmaceutical Excipients Council (IPEC), for example, plans to submit written comments to the committee about the Act's proposals. Although IPEC is supportive of the fact that the Act, if passed, would put more pressure on what a user needs to do to qualify its suppliers, the organization is concerned about the bill's call for a nofee registration of excipient plants.

"There should be a fee for them just like there is for API facilities," says David R. Schoneker, who ended his term as chairman of IPEC–Americas on Jan. 1. Schoneker is also a member of Pharmaceutical Technology's editorial advisory board. "If you have a registration process that only involves an Internet form and a registration number, well, the bad guys can do that too. Some may try to tout the fact that they have an FDA registration number as if they've been FDA-approved. A reasonable fee is necessary, and pharmaceutical companies should only be allowed to use excipients from registered excipient suppliers."

A second concern for IPEC is the Act's provision requiring FDA to inspect every facility, including excipient facilities before the facility is allowed to offer material to the marketplace. "FDA could never have enough resources to inspect all facilities which manufacture or distribute excipients. This is where third-party certification comes into play," explains Schoneker. "We think there should be inspections of excipient companies prior to using excipient suppliers. However, this can't be done by FDA alone. A combination of FDA inspection (to judge risk) and third-party certification would make sense. It's the only way to get more audit information in the hands of the users."

There is also speculation that the Obama administration will increase regulations. The new administration may help to "establish a level playing field for what the expectations are, for what is really required for a pharmaceutical user to use an excipient or ingredient from a particular supplier," says Schoneker. "It also may bring more standardization and more accountability."

Country-of-origin labeling. The revised discussion draft of the FDA Globalization Act discusses country-of-origin labeling for APIs and website listing of all drug components (including excipients). A bill proposed by Senator Sherrod Brown (D-OH) in October would amend the Federal Food, Drug, and Cosmetic Act to require country-oforigin labeling for active and inactive ingredients, or excipients (13). IPEC's position is that country-of-origin labeling will not improve safety or consumer choice. "There are many good manufacturing plants in China and India that we shouldn't be afraid of, and likewise there can be bad suppliers in the US," says Schoneker. "The key issue is who you buy from, not where you buy from; country-of-origin labeling will not help with this issue."

Import safety and certification. President George W. Bush established the Interagency Working Group for Import Safety which led to the Action Plan for Import Safety in November 2007 (14). FDA is part of the working group that finalized the plan, which calls for increased collaboration and coordination with countries and companies that export products into the US. In addition to signing two memoranda of agreement with China in late 2007 to protect food and drug imports (15), the US Department of Health and Human Services (HHS) established two programs in July 2008 tied directly to securing the pharmaceutical supply chain: joint inspections with the European Union and Australian regulators, and the use of third-party certification (16).

The joint-inspection program began in Fall 2008 as a pilot project and focuses on API manufacturing facilities. The certification program is also a pilot project, currently focusing on how best to evaluate third-party certification programs for the food industry. Depending on its success, thirdparty certification may be tested and implemented with drug suppliers as well (16).

Also, the International Conference on Harmonization Guideline Q10 Pharmaceutical Quality System was adopted in June 2008. It specifies that manufacturers include outsourcing activities within their quality systems and verify the other party's quality systems before engaging in outsourcing (17).

The US Pharmacopeia (USP) already has a certification program for APIs and excipients coming into the US. And along these lines, FDA is developing a draft guidance on good importer practices (14). In addition, the agency is working on a pharmaceutical ingredient quality assurance guidance.

Information technology. Following criticism of FDA's information technology (IT) systems for drug-establishment registration, FDA has made improvements. (FDA had not inspected the Chinese Changzhou SPL facility, the alleged site of Baxter International's heparin contamination, due to a database error.) FDA's Kelly says in addition to efforts to better identify drug firms, including firms named in applications, progress includes:

• Establishing a pilot program, to be fully implemented this year, for electronically registering and listing drugs.

• Selecting 10 contractors to receive up to a total of $2.5 billion for IT and services for the management of data centers over a decade. This funding will allow FDA to acquire, analyze, and act on data that are critical for import protection.

• Work toward the use of a universal identifier such as the Dun and Bradstreet number (or DUNS) that would allow the agency to use robust, established databases to verify the accuracy of registration information.

References

1. FDA, "Melamine Contamination in China" (Rockville, MD) Dec. 4, 2008, available at http://www.fda.gov/oc/opacom/hottopics/melamine.html, accessed Dec. 5, 2008.

2. FDA Release, "FDA Detects Melamine Contamination in Flavored Drink" (Rockville, MD), Oct. 6, 2008.

3. FDA, "Pet Food Recall (Melamine)/Tainted Animal Feed" (Rockville, MD), Feb. 6, 2008, available at http://www.fda.gov/oc/opacom/hottopics/petfood.html, accessed Dec. 5, 2008.

4. FDA, "Imported Toothpaste" (Rockville, MD) Oct. 9, 2007, available at http://www.fda.gov/oc/opacom/hottopics/toothpaste.html, accessed Dec. 5, 2008.

5. HHS, FDA Warning Letter to Ranbaxy Laboratories Limited, (Silver Spring, MD), Sept. 16, 2008.

6. PricewaterhouseCoopers, "The Changing Dynamics of Pharma Outsourcing in Asia: Are You Readjusting Your Sights?," (NY, New York), Oct. 2008.

7. P. Van Arnum, "Manufacturing Insights: Pfizer," Pharm. Technol. 32 (7), 50–52 (2008).

8. P. Van Arnum, "Outsourcing R&D in Asia: A Case Study of Pfizer," Pharm. Technol. 32 (8) Outsourcing Resources Suppl., s56–s62 (2008).

9. J. Lechleiter, "Innovation: The Cure for What Ails Us," speech at the Economic Club of Indiana, Sept. 24, 2008.

10. J. Dingell, F. Pallone, Jr., and B. Stupak, "Memorandum to the Members of the Committee on Energy and Commerce," US House of Representatives, Apr. 17, 2008.

11. US House Committee on Energy and Commerce, "Food and Drug Administration Globalization Act," Revised Discussion Draft, July 24, 2008 (Washington, DC).

12. J. Dingell, "Letter to Democratic Caucus" (Washington, DC), Nov. 6, 2008.

13. S. 3633, "Transparency in Drug Labeling Act," US Senate, 110th Congress, 2nd Session (Washington, DC), Sept. 26, 2008.

14. Interagency Working Group on Import Safety, "Import Safety—Action Plan Update, A Report to the President" (Washington, DC), July 1, 2008.

15. FDA, "Agreement between the Department of Health and Human Services of the USA and the State Food and Drug Administration of the People's Republic of China on the Safety of Drugs and Medical Devices" (Rockville, MD), Dec. 11, 2007.

16. HHS, "HHS Announces New International Programs to Enhance Drug and Food Safety" (Washington, DC), July 9, 2008.

17. ICH, Q10 Pharmaceutical Quality System (Geneva, Switzerland, June 2008), available at www.ich.org/cache/como/276-254-1.htm, accessed Dec. 10, 2008.

Post-Heparin: Baxter Responds

Baxter International (Deerfield, IL) recalled thousands of vials of heparin in early 2008 after physicians in Baxter's pharmacovigilance group detected an increase in reported adverse reactions associated with the blood thinner in the United States (1, 2). Baxter and FDA later traced contamination (oversulfated chondroitin sulfate) to the product's active pharmaceutical ingredient (API), which was supplied by Scientific Protein Laboratories' (Waunakee, WI) Changzhou, China, facility (3, 4). FDA performed an inspection in February 2008, which resulted in an April 2008 warning letter to Changzhou SPL that noted significant deviations from current good manufacturing practices of APIs (5). Pharmaceutical Technology talked to Baxter International's director of corporate communications, Erin M. Gardiner, about the event.

PharmTech: What is Baxter's current take on the heparin incident?

Baxter: The heparin contamination was an unusual, extraordinary event that exposed vulnerabilities in a very small portion of Baxter's supply chain (as well as the other companies across the globe that experienced the same tampering) that we are aggressively addressing.

PharmTech: How much does Baxter source from China for its US products?

Baxter: Less than 1% of all Baxter products sold in the US include components sourced from China. The manufacturing facilities Baxter has in China produce products to be used in China and the Asia– Pacific market.

PharmTech: What changes has Baxter made to its supply chain?

Baxter: Broadly speaking, the heparin contamination crisis has reinforced the importance of staying focused long-term on supplier quality improvements and confirmed the prudence of the Baxter initiative, which we launched well before the heparin issue. The initiative includes enhancing our audit programs' frequency and duration, degree of scrutiny of new suppliers, and applying the best technology we can to enhance our supplier quality controls. These efforts, aimed at our operations globally, include:

1. A risk-based review of suppliers
2. Additional tamper-proof measures
3. Enhanced screening and testing technologies
4. Mapping our supply chain to reduce the 'number of links in the chain'
5. Increasing scrutiny of new suppliers
6. A revamping our audit program, including improved training, duration, and frequency.

PharmTech: What more can be done to ensure supply chains are safe?

Baxter: Resting on old standards, even ones that have worked for decades, is no longer enough.... Improvements have been made in the way we oversee our suppliers, the way we test, and how we anticipate the unimaginable. Baxter's name was on the product [heparin] and regardless of how, why or where this [contamination] happened, it's our responsibility to learn from the experience and take the appropriate actions to ensure this won't happen again.

References

1. Baxter Release, "Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials," Jan. 25, 2008.

2. Baxter Release, "Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products," Feb. 28, 2008.

3. FDA, "Questions and Answers on Heparin Sodium Injection," updated July 16, 2008, available at www.fda.gov/cder/drug/infopage/heparin/heparinQA.htm.

4. J. Woodcock, FDA CDER, "Statement before the House Subcommittee on Oversight and Investigations," Apr. 29, 2008.

5. HHS, "Warning Letter to Changzhou SPL Company, Ltd. from Richard L. Friedman, CDER," Apr. 21, 2008.

Regulators Grow Global Presence

As part of the US Food and Drug Administration's "Beyond our Borders" initiative, several new FDA offices are opening overseas (see Table I). The highest number of FDA staff will be in India, where an increasing amount of regulated products are being imported into the United States, according to the FDA press office. FDA plans to use its presence to conduct more inspections in India and to work with other governments and private/public-sector entities interested in certifying that products from India destined for the export market meet the highest standards for safety, quality, and purity. HHS officials are also developing Memoranda of Understanding (MOU) with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama, according to the agency. (An MOU was signed with the Chinese State Food and Drug Administration [SFDA] in late 2007.) The memoranda focus on product safety as well as potential information-sharing and joint training for inspections (1).

Table I: US Food and Drug Administration overseas staffing.

FDA conducted 1479 inspections of foreign drug establishments between fiscal year (FY) 2002 and FY 2007 (2). The 10 most frequently inspected countries during this period, in order, were: India, Germany, Italy, Canada, United Kingdom, China, France, Japan, Switzerland, and Ireland. Ninety-four FDA inspections took place in China between FY 2002 and FY 2007; 199 took place in India.

The International Pharmaceutical Excipients Council (IPEC) and US Pharmacopeia (USP) are also expanding their presence abroad. IPEC recently established a Chinese division to promote information-sharing. IPEC–China is also providing assistance to SFDA to help revise draft excipient legislation that is better harmonized with international requirement, says IPEC–America's David R. Schoneker. An IPEC–India, IPEC-Brazil and possibly an IPEC-Argentina division may be established in the future. Also on the horizon is a possible IPEC federation to serve as an umbrella framework for the various global IPEC divisions.

In March 2008, the US Pharmacopeia (USP) signed an MOU with the Chinese Pharmacopoeia (CPH) that is similar to the FDA–SFDA memorandum. The USPCPH memorandum focuses on four areas: building joint monographs, building relationships through scientific exchange visits and joint research activities, translating the USP into Chinese (the last time the book was translated was in 1923), and establishing a joint verification/certification program with the Chinese pharmacopoeia, according to Roger L. Williams, USP executive vice-president and CEO. USP has had offices in China, as well as India, for a few years, and in August 2008, established a site in Brazil.

References

1. FDA, "Agreement between the Department of Health and Human Services of the USA and the State Food and Drug Administration of the People's Republic of China on the Safety of Drugs and Medical Devices" (Rockville, MD), Dec. 11, 2007.

2. M. Crosse, "Statement, Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce," Apr. 22, 2008.