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FDA proposes $30 million in fees to speed review of generic drugs

December 17, 2010 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: www.post-gazette.com, 12.16.2010

Generic-drug companies, led by Teva Pharmaceutical Industries, would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a Food and Drug Administration proposal.

The plan grew out of talks between the FDA and drug makers to speed reviews of low-cost copies of medicines, according to Russell Wesdyk, scientific coordinator in the FDA’s Office of Pharmaceutical Science.

Generic-drug reviews take 15 months longer on average than evaluations of brand-name products, according to the Generic Pharmaceutical Association, a Washington lobbying group. Inspections take as many as 12 months to complete, especially for products made outside the U.S., said Richard Stec, vice president of global regulatory affairs with Perrigo Co., an Allergan, Mich.-based member of the trade group.

“Getting the inspection scheduled in a timely manner is probably the biggest challenge both for FDA and for industry,” Mr. Stec said.

The FDA may waive “preapproval inspections” done after companies submit generic-drug applications, Mr. Wesdyk said last Thursday. Instead, it would rely on periodic inspections that focus on firms’ broader manufacturing practices.

The agency would still carry out preapproval inspections under the proposal when drugs are made with untested technologies or produced at a site the FDA hasn’t inspected.

More generic-drug companies are moving operations outside the U.S., making it harder for the FDA to keep pace, Janet Woodcock, director of the agency’s Drug Center, said during a September meeting to discuss the fees. The FDA inspects U.S. plants once every 30 months, compared with once every nine years for foreign plants, a September Government Accountability Office report states.

The FDA receives 800 to 900 generic-drug applications each year, compared with about 100 applications for new brand-name drugs, Mr. Wesdyk said.

The volume of work means “even with additional resources, it would be very difficult to do the number of preapproval inspections,” said Peter Beckerman, a senior adviser in the FDA’s Office of Policy, who is leading the generic-drug user fee negotiations for the agency.

Brand-name drug makers have paid the FDA fees since 1992 to help fund faster reviews.

The FDA hasn’t presented the proposal to generic-drug companies, Mr. Stec said. In addition to the Generic Pharmaceutical Association, groups involved in the fee talks include the Generic User Fee Coalition — consisting of Perrigo; Teva, Hospira of Lake Forest, Ill.; and Apotex of Toronto — and Mylan, which developed its own fee proposal.

The Generic Pharmaceutical Association and the User Fee Coalition have agreed on a system that would set targets for drug reviews and deal with the backlog of applications through separate funding, Mr. Stec said. He declined to discuss other details.

Mylan, based in Canonsburg, has pressed for a plan in which manufacturers and suppliers of active ingredients pay inspection fees in addition to fees for new applications. Mylan President Heather Bresch said her company’s proposal would generate $30 million for the FDA to standardize the frequency of inspections in the U.S. and overseas.

“You’ve got to level the playing field,” Ms. Bresch said in an interview in Washington last month. “I’m just realistic about the economic situation. Our industry is going to have to subsidize the globalization of the FDA.”

The generic-drug association and the user-fee coalition are considering Mylan’s proposal and want to reach a consensus early next year, Mr. Stec said.

The FDA plans to begin discussions with the industry early next year, Mr. Wesdyk said. Any agreement would have to be approved by Congress.

Dependence on Prescription Drugs Rise with Costs

October 01, 2010 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: Health Care Uncovered, by Brandi Funk – 9.30.2010 (http://ow.ly/2N3Sp)

It looks like government isn’t the only thing that Americans are increasingly dependent on.

A new report from the Centers for Disease Control earlier this month shows that prescription drug use in the U.S. is on the rise, with half of all Americans currently on at least one prescription drug.

Who pays for these drugs? In 2009, U.S. prescription drugs sales topped $300 billion .

Sadly, as the number of people without health insurance rise and as more insurance companies get pickier about the drugs they cover, many cannot afford to pay for these drugs.

There is no question that the rising use and cost of prescription drugs is a major cause of rising health care costs in this country so if we want affordable health care and reform, we must start here, looking for alternatives.

According to the Generic Pharmaceutical Association, generic drugs have saved Americans $734 billion in the last 10 years so ask your health care provider if switching your prescription drug to generic is a good alternative for you.

Websites such as Medtipster allow you to search for discounted generic drug programs available at pharmacies throughout the USA.

Many of these drugs are available for as little as $4 or less.

  • If your medication is available through one of these programs, you will see a list of pharmacies with pricing, in your neighborhood.
  • If your medication is not on one of the discount generic drug programs they will notify you when it is, or they will suggest a ttherapeutic drug equivalent.
  • If your medication is not available in generic form, they will search for drug brand coupons you can print and take to your local pharmacy.

Why pay more than you have to?

Other Prescription Drug Assistance Websites

http://www.xubex.com

http://www.needymeds.com

http://www.pparx.og

http://www.rxoutreach.com

Generic Drugs $ave Billions

June 02, 2009 By: PharmaSueAnn Category: Medtipster, Prescription Savings

You can save money on generics too!!!

A recent analysis from the Generic Pharmaceutical Association revealed that generic drugs saved the U.S. healthcare system more the $734 Billion dollars in the last decade.

Don’t miss out on the savings, look for generic savings and therapeutic generic alternatives to your Brand Name drugs. It is as simple as 1-2-3 at Medtipster.

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