'Improving Access to Clinical Trials Act' Passes U.S. House - Heads to President for Signature

/PRNewswire/ -- Today the U.S. House of Representatives passed the "Improving Access to Clinical Trials Act" (I-ACT), in a victory for the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

The bill, which passed the Senate Aug. 5, now goes to President Obama's desk for his signature. He is expected to sign it.

This legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public health care benefits.

Passage of this legislation is particularly important for people with CF, a rare genetic disease. A limited patient population makes it challenging to find enough people to participate in research studies evaluating the effectiveness of promising new drugs.

"Because of this groundbreaking legislation, people with CF and other rare diseases will no longer be forced to choose between critical health care coverage and participation in research that could lead to the development of a cure for our most serious illnesses," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation.

We are grateful to our champions in Congress for approving this bill, which will help move new treatments more swiftly from the lab to the patients who need them most."

Congressional Cystic Fibrosis Caucus Co-Chairs, Reps. Edward Markey, D-Mass., and Cliff Stearns, R-Fla., led the effort to pass the bill in the House. The House version of the legislation, H.R. 2866, has 141 co-sponsors.

"No one should have to choose between participating in a clinical trial and accessing the essential benefits they need. Today's bill will open doors of hope and offer the possibility of better health to those with rare diseases like cystic fibrosis. I am proud to partner with my friend and co-chairman of the Congressional Cystic Fibrosis Caucus, Congressman Cliff Stearns, in the passage of this bi-partisan bill, which now will be signed into law by President Obama. I also want to commend the Cystic Fibrosis Foundation for its incredible work on this vital issue. Today represents an important and hopeful milestone in the battle to beat devastating rare diseases that afflict millions of Americans around the country," Markey said.

Added Stearns: "As co-chair and co-founder of the Congressional Cystic Fibrosis Caucus, I commend my colleagues for approving this legislation allowing people with rare diseases such as cystic fibrosis to participate in life-saving clinical trials that provide nominal compensation without the risk of losing their health care coverage. I also deeply appreciate the work of the Cystic Fibrosis Foundation in supporting my legislation."

The Senate version of the legislation, S. 1674, was introduced by Sen. Ron Wyden, D-Ore., with Sens. Chris Dodd, D-Conn., James Inhofe, R-Okla., Richard Shelby, R-Ala., and Richard Durbin, D-Ill., as original co-sponsors. An additional 17 co-sponsors signed on.

Current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it makes them ineligible to receive government medical benefits. This penalty has stopped significant numbers of people with rare diseases from participating in clinical studies.

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FDA Approves Pancreatic Enzyme Product, Pancreaze

The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval.

Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Until today, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market.

Today’s approval of Pancreaze, manufactured by Johnson & Johnson, increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the United States who need these products. Approved pancreatic enzyme products meet FDA standards for safety, efficacy, and product quality.

“The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them,” said Donna Griebel, M.D., director of the FDA’s Division of Gastroenterology Products.

Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, FDA established a date of April 28, 2010 for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products. Supplies of approved PEPs are expected to meet demand.

Currently, the FDA is working with approved PEPs manufacturers, patient advocacy groups, and health care professional organizations to make the public aware of the availability of pancreatic enzyme products. Patients with questions about their current PEP or making a switch to a different pancreatic enzyme product should consult with their healthcare provider.

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Senate Introduces Bill to Boost Participation in Clinical Trials for Rare Diseases

/PRNewswire-/ -- Four members of the United States Senate introduced legislation today to allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare coverage, echoing a move by the House of Representatives last month.

The "Improving Access to Clinical Trials Act" is co-sponsored by Senators Ron Wyden (D-OR), Chris Dodd (D-CT), James Inhofe (R-OK) and Richard Shelby (R-AL).

Researchers who develop drugs to treat rare diseases such as cystic fibrosis often struggle to recruit participants for clinical trials because of limited patient populations. To compound the problem, current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it would make them ineligible to continue receiving government medical benefits. This financial penalty prevents significant numbers of people with rare diseases from participating in clinical studies.

"For many suffering from rare diseases, access to clinical trials is their best hope for treatment," said Senator Wyden. "This legislation will make sure the small financial incentives these people receive will not be counted against them if they are on SSI or Medicaid. Patients suffering from rare diseases should not have to choose between their best hope for treatment or losing benefits, nor be denied the access more financially fortunate patients receive."

"For those living with a rare disease, clinical drug studies can offer a ray of hope: access to cutting-edge medical technologies that may help treat or even cure a serious illness," Senator Dodd said. "Currently, individuals who receive public assistance often do not participate in compensated clinical trials for fear of losing their Medicaid or Supplemental Security Income. This legislation will remedy this inequity by ensuring that more Americans, including those who receive public assistance, have access to these potentially life-saving clinical drug studies."

"This bill allows patients with a rare disease to disregard up to $2,000 of compensation received for participation in a clinical trial in their SSI and Medicaid income calculations," said Senator Inhofe. "Though it will have a negligible impact on the federal budget, it will make a dramatic difference in the lives of those who will gain access to potentially life-saving treatments by enrolling in clinical trials as well as all those in the future whose lives will be improved by the medical advances that arise from this research.

"Scientists and researchers across our nation continually produce new therapies that have the potential to save the lives of countless Americans who suffer from life-threatening rare illnesses," said Senator Shelby. "These patients should not be forced to choose between the health benefits they desperately need and the opportunity to participate in a clinical trial that could improve their medical condition. I am confident that this legislation will open a pathway for more patients to receive life-saving treatments."

Fifty years ago, there were no drugs for people with CF and those with the disease rarely lived to attend elementary school. Today, because of the Cystic Fibrosis Foundation's focus on innovative and aggressive research, there are more than 30 potential therapies in development, and the median life expectancy is higher than 37 years.

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FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States

The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency’s unapproved drugs initiative.

Creon, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the enzymes needed to digest fats, proteins and sugars from food. Creon is approved for use in pediatric and adult patients.

The FDA had required the manufacturer of Creon to submit, and the agency has approved, a Risk Evaluation and Mitigation Strategy (REMS), which includes a Medication Guide, to advise patients on risks associated with high doses of Creon, and the theroretical risk of transmission of viral disease from pigs to patients. A rare bowel disorder, called fibrosing colonopathy, can result from a patient’s high-dose use of Creon. While this condition is serious and may require surgery, a patients’ chances of having this condition may be reduced through their adherence to dosing instructions in the labeling.

The risks of a rare bowel disorder and viral transmission described in the Medication Guide are considered to be risks related to all porcine (pig)-derived pancreatic enzyme products, including Creon.

Instructions for dosing based on weight and age should be followed carefully. Creon may be sprinkled on food. Because Creon is a delayed-release drug, patients should never crush or chew the capsule as this would cause an early release of the enzymes and a reduction in enzyme activity.

“The approval of Creon will allow patients to have access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, M.D., director, Division of Gastroenterology Products within FDA’s Center for Drug Evaluation and Research (CDER).

The FDA’s Office of Compliance and Office of New Drugs within CDER worked with Creon’s manufacturer, Solvay Pharmaceuticals, through the agency’s unapproved drugs initiative to help the company come into compliance with federal laws by obtaining FDA approval. The agency continues to encourage the manufacturers of all other unapproved pancreatic enzyme products (PEPs) to work with the agency to obtain market approval. All PEPs must obtain FDA approval by April 28, 2010, or be removed from the marketplace.

“Like other medically necessary drugs, the FDA is exercising its enforcement discretion while it works with the manufacturer toward gaining approval of these drugs,” said Deborah Autor, director, Office of Compliance, CDER. “FDA approval is critical, and the manufacturers of these products have a responsibility to the American public to ensure that patients have drugs that meet our standards of safety, effectiveness, quality, and labeling.”

People who are allergic to pork and pork products, suffer from gout or kidney disease, have difficulty swallowing, are pregnant or who plan to become pregnant, or are breastfeeding, should discuss the use of Creon with their health care professional. Common side effects of Creon include flatulence (gassiness), abdominal pain, headache, and dizziness.

CREON and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. There is a theoretical risk of contracting a viral infection from pig-derived medicines, but no human illness has been reported.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

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