The Official Medtipster Blog

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.

www.Medtipster.com Source: The Boston Globe – Christoph Westphal, 6/28/2010

If we focus too much on side effects, we might forfeit important new medications

WHEN IT comes to prescription drugs, patients expect benefits but appear intolerant of risks. What would happen in a world that accepts no risks in its pharmaceuticals? We would have very empty medicine cabinets.

Every June, 200 biotech and pharmaceutical CEOs gather in Boston. This year, the deputy commissioner of the Food and Drug Administration spoke to the group on the evolving risk-benefit analysis regarding prescription drugs. Much of the ensuing dialogue with the CEOs centered on society’s changing views of drug benefits and risks.

The first “wonder drug,” aspirin, was synthesized by Bayer in 1897 and marketed in 1899. This extremely rapid path from initial experiments to market is impossible to imagine in today’s world. Now, aspirin has some wonderful properties – it reduces inflammation, prevents blood from clotting, lowers fever, and lessens pain. Millions of Americans take aspirin every year, without a doctor’s prescription. However, side effects kill roughly 10 out of 100,000 men taking aspirin. In fact, it is possible that aspirin would not be approved today by the FDA, so dramatic is the shift in society’s risk-benefit views regarding pharmaceutical products.

That shift spelled the doom a few years ago of another drug with significant benefit, but some risk, namely Vioxx. Merck had shown beneficial effects of Vioxx in severe arthritis in thousands of patients, and the drug was approved. After Vioxx reached the market, however, the risk of death from heart attack, estimated by independent academics to be on the order of 20 to 30 out of 100,000 patients taking the drug, led Merck to remove Vioxx from the market. There are likely patients with severe arthritis who would accept the risk of side effects, in order to benefit from this effective medicine. But these patients no longer are able to make their own risk-benefit calculations. Instead, society has determined on their behalf that this therapeutic option should no longer be available to them.

How dangerous, in comparison to taking aspirin or Vioxx, is driving a car? According to the National Safety Council, the risk of dying in a car accident during one year is about 155 out of 100,000. The death rate of car usage actually appears a good deal higher than the likelihood of death caused by taking Vioxx or aspirin. Nevertheless, no one is arguing that cars should be taken off the market. Instead, society has decided that the benefits of cars outweigh their risks.

As society has shifted to a view that medications should have virtually no risks, the inevitable effect has been to reduce the flow of important new drugs. It is certainly fair to rigorously test any new medication prior to approval. In addition, any new drugs should be monitored for safety and efficacy after they have reached the market.

But society must be careful to weigh the benefits of effective new drugs for diseases that until now have been poorly treated, versus the added risks of the new medications. If we focus too much on the risks of drugs, and do not balance those risks against the benefits, fewer drugs will be approved and reach patients in need. That is a risk in and of itself.

On your next drive, remember that it may be riskier to get in your car than to take the drug Vioxx, which was shown to be highly beneficial to patients with severe arthritis, but has been removed from the market.

www.Medtipster.com Source: Wall Street Journal, May 3, 2010

Consumer complaints about certain over-the-counter children’s medications spurred an investigation that led to a recall of more than 40 different products because of manufacturing problems, according to officials at a unit of Johnson & Johnson.

The recall, announced over the weekend by the company and the U.S. Food and Drug Administration, prompted drug stores and other merchants to pull the medicines off their shelves and caused concern among parents who took steps to avoid giving the products — largely pain and allergy remedies — to their children.

A spokesman for J&J’s McNeil Consumer Healthcare unit wasn’t more specific about what issues consumers raised that led to the internal probe.

“We always receive some consumer inquiries about our products and those inquiries led to the investigation that ultimately led to this recall,” the spokesman, Marc Boston, said.

The company said there haven’t been any serious side effects reported, and the company and the FDA said the potential for harm is remote. Still, the company and the agency said the products shouldn’t be given to children for precautionary reasons.

The recall involved at least 1,000 lots of products, including pediatric versions of Tylenol, Motrin, Zyrtec and Benadryl.

Some of the liquid formulations may contain a higher concentration of their active ingredient than they should while others may contain inactive ingredients at inappropriate levels, or tiny metallic particles that are a residue of the manufacturing process, the company said.

The medicines were sold in the U.S. and Canada as well as in countries as far away as Fiji and Kuwait. All were made at a factory in Fort Washington, Pa., the FDA and the company said. Neither the company nor the FDA could say how many bottles of medicine were involved.

At English Drug, an independent pharmacy in Bethel, Conn., staffers removed several products from the store’s shelves Sunday morning after learning about the recall on the Internet. “These are very popular products, but we pulled them” out of safety concerns for consumers, said Denise McMahon, a pharmacist at the store.

In New York City, Natalia Carin said she recently gave her 2-year-old son Cole children’s Zyrtec and Motrin. He appears to be fine, she said, but added, “I’d like some information about what kind of substance this was and how dangerous it might be and what we can expect.”

Kenneth Polin, a pediatrician at Town and Country Pediatrics, with offices in Chicago and its suburbs, had heard from few worried parents Sunday, but says his advice is to turn to generic versions of the medicines. He recommended that before consumers buy a generic, they make sure to ask a pharmacist whether J&J manufactured it.

The recall is another dent in J&J’s reputation as a model of corporate responsiveness. That harks back to the deadly Tylenol poisonings in the early 1980s, when the company reacted swiftly to recall the product and inform the public.

More recently U.S. regulators have criticized J&J’s handling of product-quality issues, because of a widening series of recalls of over-the-counter medicines that accelerated late last year.

In November, the company recalled a limited number of certain bottles of Tylenol arthritis-pain caplets after identifying an uncharacteristic smell or taste associated with the products.

In December, J&J had to expand the recall to include all lots of the product. A month later, J&J widened the recall again to include other brands such as Motrin and Benadryl.

That resulted in the FDA sending J&J a warning letter saying the company had violated good-manufacturing rules at its Las Piedras, Puerto Rico, plant.

www.Medtipster.com Source: Los Angeles Times, 04/09/2010

For many of the one-in-three American adults who have high blood pressure, a cheaper alternative to brand-name medications is about to become available.

Losartin, the angiotensin II receptor blocker marketed under the brand names Cozaar and Hyzaar (the latter of which combines losartin with the diuretic hydrochlorothiazide) for more than a decade, will become available in generic formulations, following a Food and Drug Administration decision announced this week.

Four drugmakers have won the FDA’s blessing to make and market the hypertension drugs in generic forms.

Wasting no time, the first company to receive broad FDA approval to market the generic drug, Teva, announced yesterday the launch of its losartin potassium-film-coated tablets in 25-milligram, 50-milligram and 100-milligram strengths.

If you’re a patient being treated with other brand-name angiotension receptor blockers for hypertension — Atacand, Avapro and Diovan — you may have to wait for less expensive drugs.

Atacand won’t be available in generic form before 2011 at the earliest, and Avapro and Diovan are not expected to reach the market in generic form before 2012.

The FDA’s Office of Generic Drugs states flatly that generic drugs are the same as the brand-name first-to-market drugs they copy — same active ingredient, same means of action, same safety and effectiveness profile — they’re just much cheaper. But the formulations in which those active ingredients are packaged do change when they are reproduced as generics.

For a very small number of people and with a few types of drugs, pharmacologists acknowledge that that can make a difference in how — or even how well — a drug works.

So, if the size, shape, color or brand marking of your regular prescription blood pressure medication changes in the next few months (and if it suddenly becomes less expensive), rejoice over your lower bill. But also, be sure to ask the pharmacist if you have been switched to a generic version of the drug your physician originally prescribed.

And for a couple of weeks after switching to a generic, check your blood pressure a bit more regularly to make sure your hypertension is still under control with the medication.

One more warning: There are five other classes of medications used to treat high blood pressure, and all do so by different means than the angiotension II receptor blockers.

Insurance companies and pharmacy benefits managers are aggressive in trying to switch patients to a new generic drug if it can save money, even if it means switching a patient to a new class of drugs.

The practice is called therapeutic substitution. Sometimes, it can often save you money while managing your condition just fine.

But for some individuals, another class of medication won’t work as well or may not be recommended.

Again, ask your pharmacist if you don’t recognize the medication you’re getting, and check with your physician if the switch is something you haven’t discussed.

Generic drugs are a safe and effective alternative for many reasons.

Not only individuals who require inexpensive health care alternatives commonly opt to use generics, but for economic reasons, everyone should think generics first. Generic drugs use the same active ingredients and carry the same side effects as their brand name counterpart. Generics and brand-name drugs are identical in their safety, purpose, effectiveness, and administration method. By identical, it could be defined as the drugs have identical active components or employ a bioequivalent composition of the brand-name equivalent. They are deemed bioequivalent if their pace and accessibility after being given in an identical quantity have like effects. Having parallel effects, both medicine forms have the same effects and amount of effectiveness.

You may ask, if brand name and generic medicines are so similar, why are brand name drugs more inexpensive than generic drugs? The expensive price of branded drugs stem from their research, process, and promotion. Since the brand name drug is recently made, a copyright is provided to grant them sole rights in selling the medicine. When these branded medicines are nearing their patent termination, other manufacturers go to the Food and Drug Administration to permit them to manufacture the generics.

Generic drug manufacturers don’t have a patent, thus the logic for their lesser price. Other generics can have a patent for the composition but not for the active ingredient. Because the generic manufacturers only have to apply and have no initial R&D prices, they can offer the drug at a smaller cost. Economics also have a function in the generic drug’s cheaper value. Since more producers can produce a generic version, there is higher competition in the economy. For one manufacturer to have a lead against the other, they must sell the medicine at a less expensive cost. With more customers, they can opt to have sales at a cheaper value.

Since generic drugs get their smaller prices from economic factors, it’s evident that a medicine’s value does not determine its quality. Some people are under the misconception that generic drugs have a smaller cost because they’re not as effective. Prior to reaching such a conclusion, you need to do research and comprehend the costing process behind it. The Food and Drug Administration makes certain that generic producers adhere to their criteria. These criteria are implemented to branded and generic medicine companies. Anyone with this price misreading should also know that 50 percent of the generics produced are done by branded manufacturers. Don’t be alarmed if the generic version applies a different combination of inactive ingredients. The differences also stem from a copyright issue. US copyright laws require that generics cannot look identical as the brand-name equivalent. Nonetheless, the generic will still use the same active ingredient process and mix to cause identical efficacy and results.