FDA Bill Grants Power to Search Overseas Rx Plants

WASHINGTON - A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president's desk after an overwhelming approval in the U.S. Senate.
The Senate approved the must-pass piece of the legislation by a vote of 92-4, and President Barack Obama is expected to sign it into law within days.
The core of the bill is critical to the FDA: It bolsters the agency's budget with billions of dollars in drug industry fees for scientists who review new medicines. For the first time, generic drugmakers will pay review fees to speed the approval of their products. Branded drugmakers have paid those fees for 20 years.
Lawmakers seized on the legislation to address recent concerns about the safety and quality of prescription medicines, especially those that are imported. The bill also gives the FDA new tools to fight counterfeiting and drug shortages, which have made headlines in the past year.
"This legislation will help bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs," said Sens. Tom Harkin, D-Iowa, and Mike Enzi, R-Wyoming, who guided the bill through the Senate.
Public health experts say the most significant changes for consumers involve how FDA inspectors oversee foreign drug manufacturing facilities.
For more than 70 years, the agency has focused its inspections on U.S. factories. But most companies have moved their operations overseas to take advantage of cheaper labor and materials. Between 2001 and 2008 the number of U.S. drugs made outside of the country doubled, according FDA figures.
The bill passed by Congress would drop a requirement that FDA inspect all U.S. drug factories every two years and let it focus on foreign facilities, which it now typically inspects every nine years. The new bill requires that FDA inspectors target the most problematic manufacturing sites, regardless of whether they're in the U.S. or overseas.
"This legislation will, for the first time, enable the FDA to regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications," said Allan Coukell, director of the Pew Charitable Trusts' medical programs
The risks of unchecked foreign drug manufacturing hit home in 2008, when hundreds of U.S. patients suffered allergic reactions — some fatal — to a blood thinner imported from China. An FDA investigation concluded the drug had been contaminated, to reduce costs, with an ingredient that mimics the blood thinner heparin.
The bill would raise the maximum prison sentence for drug counterfeiting to 20 years, or $4 million, from just three years or $10,000, under current law.
Despite months of negotiation, the bill does not include a national tracking system, which public health advocates say is critical to weeding out counterfeit pharmaceuticals from the U.S. supply chain. Lawmakers said they couldn't bridge longtime disagreements between the FDA and drugmakers over the scope and cost of the system, which would track shipments using electronic codes.
The legislation's underlying purpose is to renew, through 2017, a program under which drugmakers pay the FDA set fees for the review of new products. Since it first passed in 1992, the Prescription Drug User Fee Act has allowed the FDA to hire hundreds of additional scientists in return for meeting certain performance goals.
Under the new bill, the FDA would collect $6.4 billion in fees from companies over five years beginning in 2013. About $1.8 billion, or nearly 30 percent, would come from new fees, including the first to be paid by generic drugmakers.
Whereas most new drugs are reviewed in 10 months, the typical review for a generic drug takes over 30 months. The FDA has a backlog of more than 2,700 generic drug applications awaiting review, according to the Generic Pharmaceutical Association. The new fees will be used to hire more scientists to speed up clearance of generic drugs.
The legislation also renews a similar program covering medical devices.
Senators hailed the legislation as a rare example of cooperation between Republicans and Democrats, but the fee agreements at its heart had almost nothing to do with Congress.
Those arrangements were worked out during more than a year of closed-door negotiations between the FDA and industry groups. The portion of FDA's drug review budget that's underwritten by industry has steadily increased since 1992 and is now more than 60 percent.
Consumer advocates complain that the agency has become too dependent on the companies it regulates. They say they were shut out of the discussions.

http://www.startribune.com/business/160442335.html

New Mexico Tightens Rx Drug System

Seeking to combat a growing epidemic of prescription drug abuse in New Mexico, the state Board of Pharmacy voted Thursday to strengthen an existing monitoring program that tracks drug prescriptions, who dispenses them and under what circumstances.

Other rule changes adopted by the board, which will go into effect later this year, will require additional training for pharmacists on how to use that monitoring system, limit the supply of drugs prescribed in certain situations and tighten language regarding penalties for anyone lawfully allowed to dispense prescription drugs who withholds or falsifies information going into the tracking system.

"We're accomplishing great things by educating pharmacists," Danny Cross, a board member and pharmacist, said during a well-attended, two-hour hearing Thursday at the board's Albuquerque headquarters. "This is not punishing pharmacists. This is to educate pharmacists, practitioners and patients ... to help control this drug abuse problem."

Over the past decade, New Mexico has experienced a spike both in the number of pills being prescribed and the number of drug overdose deaths reported. From 2001 to 2010, the sales of opioid pain relievers rose by 131 percent in the state, from 489,809 grams to 1.13 million grams, according to the state Department of Health. Meanwhile, over roughly the same period, the state's drug overdose death rate increased by 79 percent -- from the 261 people who died in 2001 to the 468 who lost their lives in 2010.

The epidemic, of course, is not confined to New Mexico. Nationwide, the National Survey on Drug Use and Health estimated that in 2010, 7 million people used prescription drugs nonmedically.

But New Mexico's rate of drug overdose deaths is the highest in the nation.

Even some of the state's pharmacists don't understand the size of the problem, Dale Tinker told board members Thursday.

"It's a lot bigger issue than I think they thought," Tinker, a lobbyist for the New Mexico Pharmacists Association, said.

Tackling the prescription drug abuse problem is complex because it involves multiple challenges. Emergency rooms might see addicts looking for their next fix or dealers trying to corral a new supply, but they also come into contact with patients who want to get off the drugs and don't know where else to turn.

One of the challenges is to ensure that those who are handed a white bag with a bottle of pills inside are the people who truly need it. Another is ensuring that those who hand the prescribed drugs to individuals have access to up-to-date information that the prescription is appropriate.

The rules adopted Thursday represent an attempt to address those problems, mostly by ensuring pharmacists and pharmacist interns are better armed with information on how to prevent abuse and stop addiction before it starts, officials said.

One of the changes would give New Mexico's pharmacists the ability to request from the state's prescription monitoring system a report detailing the past year of a patient's history if he or she exhibits signs of potential abuse or misuse of opiate drugs or if the prescription order is from a dispenser with whom the pharmacist is unfamiliar.

Also under the new rules, practitioners including doctors, dentists, veterinarians, pharmacists and certified nurse practitioners would have to register and train for the state's monitoring program when they complete their controlled-substance registration.

That electronic database gives doctors and pharmacists access to a patient's prescription-drug history. Providers update the information at least every seven days -- an improvement over the monthly updates that were previously all that was required.

"It's a message from the board," said Bill Harvey, the Board of Pharmacy's director. "It's about professional expectations."

The board also voted to require that any controlled-substance prescriptions that go directly to a patient could not be refilled before 75 percent of the days have passed since the prescription was filled, unless a doctor approves the refill. Similarly, prescriptions that go to a patient indirectly, such as through a mail-order service, couldn't be refilled until 66 percent of the days in a 90-day supply have gone by, or half of the days in a 30-day supply, unless a doctor authorizes the refill.

Another change would limit new over-the-phone prescriptions for some controlled substances to a 10-day supply that cannot be refilled. Currently, a phone prescription for those drugs can be refilled up to five times in six months.

Board members seemed intent on adopting the changes Thursday despite potential obstacles.

"We're trying to get things in place sooner rather than later," board member Buffy Saavedra said at one point when someone in the audience asked a question that appeared not to be answered in the proposed rules.

At another point, the board learned that a proposed change would bar the state from qualifying for future U.S. Drug Enforcement Administration funding for the state's prescription monitoring program.

The change under consideration would allow individual pharmacists to access and use the state's prescription monitoring program instead of circumscribing access only to pharmacies, which the DEA requires for a state to qualify for certain types of funding. Many pharmacies employ more than one pharmacist, officials pointed out Thursday. And by having individual pharmacists register to use the system, New Mexico officials believe the state can better track potential abuse.

"This is a big enough problem" that the board should go ahead with the change despite the potential loss of future federal funding, pharmacy board chairman Richard Mazzoni said.

http://www.hispanicbusiness.com/2012/6/22/new_mexico_tightens_prescription_drug_system.htm