WASHINGTON --- Senator Chuck Grassley has asked the Food and Drug Administration about progress made to improve foreign drug inspection, following commitments made by the agency when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.

"My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn't have a system to check the quality of upstream providers of the drug components.  In fact, pharmaceutical companies aren't required to have those checks in place," Grassley said.  "I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets."

Since 2007, Grassley also has twice filed legislation to dramatically beef up the FDA's foreign inspection operation, including enhanced enforcement for quality and safety violations.  The legislation, which Grassley had introduced with the late Senator Kennedy, hasn't been passed by Congress.  China is one of the largest exporters of pharmaceutical products to the United States.  Following questions raised by Grassley and others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.

Below is the text of the letter Grassley sent today to the FDA Commissioner.

February 16, 2010

The Honorable Margaret A. Hamburg

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Commissioner Hamburg:

As Ranking Member of the United States Senate Committee on Finance (Committee), I have a special responsibility to the more than 100 million Americans who receive health care coverage under those programs to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices.

In 2007 and 2008, I wrote a series of letters to the Food and Drug Administration (FDA/Agency) inquiring about the Agency's oversight of foreign-made drugs and active pharmaceutical ingredients (API).  I appreciate FDA's responses to my letters and look forward to the Agency's continued cooperation.

Almost two years ago, in February 2008, Baxter International (Baxter) had announced that it had temporarily suspended production of its blood thinner heparin because of increased reports of serious adverse events, in particular allergic reactions, associated with the use of its drug.  The company recalled its heparin sodium injection single-dose vials, the remainder of its multiple-dose vials, and the heparin flush products from the market.  Prior to the recall of its products, Baxter manufactured about 50 percent of the heparin used in the United States.  Thus, there were serious concerns about whether or not this country would have enough heparin to meet patient needs.

After several months of investigation, the FDA and the Centers for Disease Control and Prevention concluded that the adverse events were caused by heparin contaminated with oversulfated chondroitin sulfate.  According to the FDA, this contaminant was found in heparin API produced by Baxter's API supplier in China, Changzhou Scientific Protein Laboratories (SPL), as well as more than 10 other Chinese facilities in the heparin supply chain.  In addition, the Agency revealed that due to human error, the FDA had failed to conduct a pre-approval inspection of Changzhou SPL in accordance with its pre-approval inspections program to ensure compliance with current good manufacturing practices (CGMP).

Despite its own audits and inspections of the API supplier, Baxter did not discover that its heparin API supply was contaminated because the company did not have mechanisms in place to ensure that the upstream providers, such as the crude heparin processors and slaughterhouses, were providing quality product to Changzhou SPL.  Baxter and other heparin manufacturers, however, are not required to have such mechanisms in place.  FDA has stated that API and drug manufacturers "frequently audit suppliers of critical materials" but the audits are not a requirement of the CGMP regulations for finished pharmaceuticals.  Nonetheless, there was one heparin manufacturer, APP Pharmaceuticals, which had a traceable distribution system that did allow it to trace crude heparin from the API supplier to the workshops and pig farms.  That company was able to increase its heparin production capacity and take over as the major supplier for the U.S. market after Baxter's product recalls.

Investigation of the contamination of the U.S. heparin supply in 2008 highlighted the need to improve FDA's protection of the safety of products made in this country and abroad.  In fact, the FDA acknowledged at a press conference on April 21, 2008 that the heparin problem "illustrated the need for [the FDA] to focus on enhanced regulation and scrutiny of the whole supply chain for drugs, including all sources of materials, including the natural sources."  In the Agency's response to me, dated June 5, 2009, the FDA also stated that "Aside from a traceable distribution system, it is imperative that both the API and drug product manufacturer establish and implement procedures and controls to secure and assure the integrity of the supply and distribution chain."

In response to the heparin contamination, the FDA announced a number of efforts it was implementing to prevent similar incidents from occurring in the future, including the establishment of an FDA presence abroad by opening field offices in China, India and Latin America, as well as the pursuit of international agreements to augment its foreign inspection program.  The FDA also stated that the FDA and international regulators had agreed to hold an inspection summit in 2009 to apply the lessons learned from the heparin contamination.  In addition, the FDA stated in its letter to me that it is collaborating with several pharmaceutical associations "to establish more robust systems and procedures to qualify suppliers of pharmaceutical ingredients and assure the identity and purity of batches of incoming ingredients."

I am writing today to follow up on the status of FDA's initiatives to improve its foreign drug inspection program, in particular any efforts to prevent tainted final dosage forms and API from entering this country.  I would also appreciate a response to the following requests:

· A reporting of FDA's plans to ensure the safety and quality of drug products that are imported into this country, including efforts to improve surveillance, technology and testing capabilities, to harmonize regulatory standards and procedures, and to enhance the Agency's regulation of the whole supply chain of drugs.

· If FDA conducted its own assessment of how the Agency handled the heparin contamination, a copy of any report or memorandum generated from that assessment, including any recommendations and lessons learned.

· A status report on FDA's review of reports of adverse events occurring after heparin administration and the number of deaths and adverse events that have been determined to be epidemiologically associated with use of the contaminated product.  During the April 21, 2008 FDA press conference, the Agency stated that there were 81 deaths linked to the allergic reactions that may have been caused by contaminated heparin.  A month earlier, on March 5, 2008, the Agency stated that it had received 785 reports of adverse events.  FDA's webpage on adverse event reports and heparin, last updated July 1, 2009, shows that between January 1, 2007 through May 31, 2008 there were 146 reported deaths that included one or more allergic symptoms that is associated with use of the contaminated heparin.  The webpage, however, does not identify the total number of other adverse events reported to the FDA.

Thank you for your assistance on this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance

Q:        What internship opportunities do you offer to Iowa students?

A: I strongly encourage and welcome college-age Iowans to intern in my Washington and Iowa offices.  Internships are available during the spring and fall semesters and for two six-week summer sessions.  Internships are an excellent educational opportunity where students get first-hand exposure to the legislative branch and learn about the process of representative government that's at the heart of America's democracy.  Depending on the college, these internships may qualify for course credit.  Internships also are an excellent way for young people to gain work experience in an area of interest.  More than half of the current permanent staff members in my office were interns.

Q:        What type of work do interns do?

A: Interns get put to work in my office.  They're assigned their own desks and responsibilities.  Duties include assisting permanent staff members in the administrative, legislative and communications departments, as well as the staff I hire for the Finance and Judiciary committees in the Senate.  Tasks include scheduling appointments, giving Capitol tours, answering phones, organizing press clippings, helping constituents with questions, drafting letters to government agencies, researching issues and policy proposals, and more.

Q:        How do students apply for your internships?

A: Interested students should visit http://grassley.senate.gov, print out a form, and send applications to cory_crowley@grassley.senate.gov or 202-224-6020 (fax).  Applying by email or fax avoids security-related delays in postal mail delivery to the U.S. Senate office buildings.  Also, my offices in Cedar Rapids, Council Bluffs, Davenport, Des Moines, Sioux City and Waterloo, as well as the placement offices of Iowa colleges and universities, all have copies of Grassley internship application forms.  The application deadline for Summer 2010 internships is March 15, 2010.  I hope many students consider an internship.  If you have questions, please call my internship coordinator, Cory Crowley, at 202-224-3744.

WASHINGTON - Senator Chuck Grassley said that the U.S. Department of Homeland Security's Federal Emergency Management Agency (FEMA) has awarded competitive grants totaling $1,544,834 to Iowa Fire Departments through the Assistance to Firefighters Grants' Operations and Safety and Vehicle Acquisition Programs.

"Day in and day out, firefighters put their lives on the line for the good of the community," Grassley said. "It's important that firefighters have the necessary equipment and training to help keep the community safe."

FEMA will distribute the money as shown below ordered alphabetically by town.

Through the Operations and Safety Program:

· Ames Fire Department in Ames will receive $46,591.

· Anamosa Volunteer Fire Department in Anamosa will receive $28,975.

· Bellevue Volunteer Fire Department in Bellevue will receive $93,338.

· Chester Fire Department in Chester will receive $32,640.

· Coggon Fire Department in Coggon will receive $30,482.

· Coin Fire and Rescue in Coin will receive $79,800.

· Douds Community Fire Department in Douds will receive $17,775.

· Elliott Volunteer Fire Department in Elliott will receive $8,550.

· Farmersburg Volunteer Fire Company in Farmersburg will receive $15,675.

· Frederika Volunteer Fire Department in Frederika will receive $45,033.

· Garrison Fire Department in Garrison will receive $5,320.

· Geneva Fire Department in Geneva will receive $23,361.

· Grand Mound Volunteer Fire Company in Grand Mound will receive $36,262.

· Marcus Fire Department in Marcus will receive $32,437.

· Meriden Volunteer Fire Department in Meriden will receive $6,012.

· Amana Benefited Fire District in Middle Amana will receive $127,103.

· Morning Sun Fire Department in Morning Sun will receive $75,150.

· Newton Fire Department in Newton will receive $54,390.

· Panama/Washington Township will receive $33,250.

· Pulaski Volunteer Fire Department in Pulaski will receive $38,885.

· Victor Fire Department in Victor will receive $47,358.

· Washta Fire Service in Washta will receive $33,155.

· Welton Volunteer Fire Company in Welton will receive $40,480.

Through the Vehicle Acquisition Program:

· Batavia Volunteer Fire Department in Batavia will receive $154,850.

· Douds Community Fire Department in Douds will receive $58,095.

· Indiana Township Fire Department in Knoxville will receive $142,500.

· McCallsburg-Warren Township Fire/EMS Agency in McCallsburg will receive $123,367.

· Winfield Benefited Fire District in Winfield will receive $114,000.

The Assistance to Firefighters Grants Operations and Safety Program supplements training, equipment, personal protective equipment, wellness and fitness, and health and safety modifications to stations and facilities.

The Assistance to Firefighters Grants Vehicle Acquisition Program helps purchase vehicles including, but not limited to, pumpers, aerials, quints, brush trucks, tankers/tenders, rescue vehicles, ambulances, foam units and fireboats.

-30-