Summary of FDA bill passed by Congress

Summary of FDA bill passed by Congress

Associated Press – Tue, Jun 26, 2012

WASHINGTON (AP) — President Obama is expected to sign into law a mammoth bill passed by Congress Tuesday that reshapes how the Food and Drug Administration assures the safety of the drug supply, particularly imported medicines.

The bill is a must-pass piece of legislation because it extends the 20-year program that helps fund the FDA's budget for reviewing new drugs and medical implants. But lawmakers added dozens of provisions influencing FDA policies and the drug industry.

Here's a look at some of the key changes the bill would bring:

FOREIGN INSPECTIONS: Gives the FDA more leeway to inspect drug factories in China, India and other foreign countries. FDA has long been required to inspect U.S. manufacturing sites every two years, but most drug ingredients are now made overseas. The bill frees FDA inspectors to go after foreign drug plants.

COUNTERFEIT DRUGS: Hikes the maximum penalty for drug counterfeiting to $4 million or 20 years in prison. The current maximums are $10,000 or three years in prison. Drug counterfeiting has risen steadily over the past decade, and drugmakers reported more than 1,700 worldwide last year. The FDA is investigating two faked batches of the cancer drug Avastin that reached the U.S. this year from the Middle East by way of European supply chains.

FDA REVIEW FEES: Renews, through 2017, a program under which drugmakers pay the FDA to review new medications. For the first time, it also requires generic drugmakers to pay for reviews, adding $299 million in annual fees to the $693 million paid by makers of branded drugs. The bill also renews a similar program for reviews of medical devices.

BREAKTHROUGH DRUGS: Relaxes certain requirements — including allowing smaller and shorter clinical studies — to speed approval of drugs that appear to offer innovative treatments for life-threatening diseases.

OUTSIDE INSPECTORS: Allows drugmakers to hire non-government inspectors to assess whether factories are meeting U.S. quality standards. These inspections wouldn't take the place of the FDA's but could be used to bolster a company's safety record.

DRUG SHORTAGES: Requires drugmakers to notify the government at least six months before discontinuing production of a drug. More than 280 drugs are currently in short supply, creating life-threatening delays for patients with cancer and other serious diseases. The shortages are driven by factors including consolidation in the pharmaceutical industry.

SYNTHETIC DRUGS: Bans 28 chemicals used in synthetic drugs known as "bath salts" that are often sold at corner stores as hygiene products, incense or plant food and can trigger bizarre and violent behavior.

Amendment with Respect to Misbranding Contained in Senate Bill 3187

The final version of Senate Bill 3187 as passed and headed ot the President's desk can be read by clicking here. 

One amendment provided for in the bill is an amendment to the misbranding provision as follows:

SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

Section 502 (21 U.S.C. 352) is amended by adding at the end the following:

‘(aa) If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 744A(a)(4) or for which identifying information required by section 744B(f) has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.’.

From American Society of Health-System Pharmacists

News Capsule

Drug Shortages Bill Headed to White House

6/27/2012

Thanks to ASHP’s multi-year effort to educate Congress about the public health crisis caused by drug shortages, along with work to build broad based support for the legislation in the health care community, we are closer than ever to protecting patients from the dangers posed by drug shortages. Today, the Senate passed the final version of S. 3187, “The Food and Drug Administration Safety and Innovation Act,” which included ASHP-supported drug shortages provisions. The House of Representatives passed the bill last week. The bill now goes to the President for his signature. 

“This is a very important achievement for ASHP,“ said chief executive officer Paul W. Abramowitz, Pharm.D., FASHP. “We are gratified that the determined efforts of our members and our staff resulted in this resounding victory for patients.”

ASHP is widely viewed as the most credible source of information on drug shortages. In a year when Congress experienced inertia due to partisan disagreements, the Society took the lead in bringing both parties together to help address the drug shortages crisis in a bipartisan, rational, and thoughtful manner. The Society, in collaboration with key partners, including the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP), worked closely with legislators to develop the drug shortages provisions.

ASHP championed the provision which became the centerpiece of the drug shortages legislation –an early notification system that requires drug manufacturers to notify the Food and Drug Administration (FDA) of production problems or if a product will be discontinued. Failure to comply with the early notification requirement will trigger a letter from FDA.

The bill also gives the FDA authority to expedite the review of products and new drug applications; creates a generic user fee program; and allows for repackaging of medications in short supply to be used within the same health system. 

President Obama is expected to sign the bill in the coming days. 

Pharmacies Receive Suspicious Offers of Wholesale Drugs; Importance of Following FDA Guidelines to Protect Patients Stressed

Several pharmacies in the Charlotte, NC, area have been approached by questionable drug wholesalers attempting to sell them drug supplies that may be fake, reports WSOCTV. One pharmacy owner indicated that he received calls from companies claiming to be new wholesalers on a daily basis. He indicated further that he avoids working with such companies for fear that they may be distributing dangerous counterfeits, and that he only buys drug supplies directly from the drug manufacturer. 

In an April 2012 FDA statement, the agency urges the health care community “to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States.” The statement was issued following FDA’s action of requesting that medical practices in several states stop administering drugs purchased from any foreign or unlicensed source. In the statement, FDA notes that the “Verify Wholesale Drug Distributor Licenses” FDA Web page may be used to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business. Also, suspected criminal activity can be reported to FDA's OCI by calling 800/551-3989 or completing the online form on the OCI Web Site. 

Another way that pharmacies can be assured of the legitimacy of a wholesale distributor is to look for NABP’s Verified-Accredited Wholesale Distributors^® (VAWD^®) Seal. Those wholesale distributors that achieve VAWD accreditation are in compliance with state and federal laws and NABP's VAWD criteria. Wholesale distributers that display the VAWD Seal as part of their accreditation have undergone a criteria compliance review, including a rigorous review of their operating policies and procedures, licensure verification, survey of facility and operations, background checks, and screening through the NABP Clearinghouse. Accredited facilities are reviewed annually and undergo a site survey every three years. Created in 2004, the accreditation program plays a pivotal role in preventing counterfeit drugs from entering the US drug supply.