Speedy Drug Approvals Have Become the Rule, Not the Exception

By Margot Sanger-Katz

Congress has over the past few decades passed a series of special approval pathways for important drugs that treat life-threatening or rare diseases. This week, a new bill introduced in the House could add two more.

You might expect these existing special programs to represent a small fraction of new and unusual drugs. But data from the Food and Drug Administration show that a majority of recent drug development has been in therapies that qualify for at least one of these programs. About a third of recently approved drugs qualify for two or more of five special approval programs.

Dr. Kesselheim, an associate professor of medicine at Harvard Medical School, said the popularity of the expedited programs could be worrisome; the expedited pathways typically require less evidence of a drug’s efficacy or safety than the standard process. “These pathways were intended for very urgent circumstances of serious life-threatening conditions, or no other reasonable clinical alternatives,” he said. “They were originally intended as the exceptions, but now the exceptions are beginning to swallow the rule.”

The most recent approval category was created by legislation in 2012. So-called “breakthrough therapies,” like the blockbuster hepatitis C treatment Sovaldi, represented nine of the 41 drugs approved last year. Over 80 drugs in development have earned the designation and will go through the breakthrough approval process. Drugs that qualify can be approved through trials that are smaller or if they show changes in a biological marker of disease — like the size of a tumor or the results of a blood test — instead of the standard measures of symptoms or survival. The details are different, but three other expedited review paths share somewhat similar features.

The first such program, called Fast Track, was passed in the late 1980s to help speed the approval of treatments for H.I.V./AIDS. There’s also a program called Priority Review, and another, Accelerated Approval.

There’s also the Orphan Drug Act, passed in 1983 to encourage drugmakers to develop drugs to treat rare diseases. Such diseases were rarely a target of drug development before that because small patient populations made it hard for drugmakers to make back their investment. But the law made it possible for drugmakers to test the drugs in smaller patient populations and to obtain guaranteed market exclusivity. The path has become enormously popular, resulting in the development of (often extremely expensive) drugs for very rare genetic diseases, and also, increasingly,cancer treatments for select patient groups. Keytruda, a lung cancer drug produced by Merck, for example, was approved through the program last year.

The legislation introduced this week, the 21st Century Cures Act, is a wide-reaching bill aimed at improving medical innovation and reforming the F.D.A.’s approval process for drugs and medical devices. (My colleague Sabrina Tavernese has an article describing its ambitions and main features.) It includes two new special categories for drugs that can qualify for special status. One, an approval path for “dormant therapies,” is still uncertain.

The current legislation leaves a hole where language describing the process may go. A discussion document released earlier this year indicated that drugs qualifying for the program could get as many as 15 years of guaranteed patent exclusivity. A smaller program, for new antibiotic drugs, would give a speedier review for such drugs if they are marketed only for limited populations. The Senate is considering some similar measures.

The F.D.A. has published a detailed review of its special programs, which it says has helped the agency speed up review of new drugs. The F.D.A. now approves new drugs, on average, more quickly than European and Japanese authorities, with about 60 percent of new drugs approved by the F.D.A. first.

The popularity of the programs is no sign that drug companies are doing anything wrong. The F.D.A. determines which compounds qualify for the various programs, and it has been somewhat expansive in its definitions. Industry analysts also say that the companies have shifted their research priorities toward the special categories — an outcome members of Congress sought by giving such drugs enhanced incentives. And the bipartisan passage of additional approval routes suggests that members of Congress think it is still too hard for some important drugs to be developed and approved.

Senator Michael Bennet of Colorado, a Democrat who helped write the breakthrough therapy provision, says he has been surprised by the popularity of the program, but pleasantly so. “The Breakthrough Therapy pathway has been more successful than we anticipated,” he said. “That’s good news.”


FDA’s New Safety Plan for Opioids

The Food and Drug Administration has taken a stand against opioid abuse with their new safety measures.

This plan is a result of the fast growing prescription drug epidemic in the United States. Opioids are at the heart of this widespread debate, as they are prescribed for chronic pain, and sometimes over prescribed or abused because of their highly addictive qualities.

The abuse of common opioids such as OxyContin, hydromorphone, oxymorphone, and fentanyl have contributed to the increase in annual opioid related deaths. “In 2008, nearly 15,000 Americans died where opioids were involved. In 2009, that number went up to 16,000” according to the FDA.

In order to cut down on the abuse of these drugs the FDA has established guidelines for manufactures to better educate physicians.

“The education guidelines will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs.”

For more information please read the full article HERE.

Other information provided by the FDA.

~Professional Medical Corp.

FDA says No on Banning BPA

Recently, the FDA has rejected a petition from environmentalists that would ban the plastic hardening chemical bisphenol-A (BPA) from all food and drink packaging. On March 30th, the FDA announced the petitioners did not present compelling scientific evidence that would validate the new restrictions on this chemical.

There are some evidence that BPA causes harm to the reproductive and nervous systems if exposed to this chemical. It is known that 90% of Americans have traces of BPA in their bodies, because if our constant exposure of bottles, canned food, and other containers. The FDA defended their decision by saying that those findings can’t be applied to humans and any study conducted so far are too small to be conclusive. The studies had researchers inject BPA into animals, but on the other hand, humans ingest the chemical through their diet over longer periods of time. Humans supposedly digest and remove BPA more quickly than any lab animal. The FDA are concerned that there might be a larger effect on young children, therefore are spending $30 million to conduct further studies.

Many companies aren’t waiting for the ban to happen as they are responding to consumer demand to remove BPA from their products. Some examples are Wal-Mart, Toys “R” Us and Campbell’s Soup.

What do you think about this BPA controversy?

Read the original article here –Courtesy of Times Healthland

Professional Medical

Don’t Eat Too Much Black Licorice This Halloween

The FDA warns the public that eating too much black licorice is not good for your health. This is only if you eat a ton of licorice daily—about 2 ounces of black licorice each day for at least two weeks. The consequences of eating too much leads to irregular heart rhythm which could land you in the emergency room.

The reason for this is glycyrrhizin which is a sweetening compound found in licorice root. When you eat an excessive amount of this, the compound causes your body’s potassium levels to decline which leads to irregular heartbeat and high blood pressure.

Overall, black licorice does not have any permanent health effects and that a lot of licorice flavored products don’t have any real licorice in them. Last year, they only reported one case.

Happy Halloween from the Professional Medical Corp. Team! Have Fun and be Safe!


Read original article here—Courtesy of Times Healthland

Tougher rules for Sunscreen Labeling (Finally!)

The FDA has recently announced stricter rules for sunscreen manufacturers on labeling their sun protection claims. There are new provisions that permit simpler sunscreen labels and require the manufacturers to test their product’s effectiveness against UVA and UVB. The UVB rays are known to cause sunburn and both UVA and UVB rays are the foundation to cause skin cancer and wrinkling.

The FDA has been considering the new rules since 1978 and will turn into laws by next summer. They have found that any products with SPF of 2-14 are not effective in reducing the chance of skin cancer or premature skin aging, therefore must include a warning explaining that it hasn’t been proven to reduce the risks of cancer or skin aging. Interestingly enough, the FDA has suggest removing any SPF labels above 50, because they haven’t found any verification that sunscreens with that high of SPFs could give anyone better protection. The administration is continuing to research on the claim until further evidence has been found.

Also, the FDA is requiring all manufacturers to remove words such as “waterproof,” and “sweat-proof” from labels, because they are misleading to the consumers. They have instructed them to use terms such as “water-resistant” and they must label how many minutes that the product could uphold sun protection.

Read the rest of the article here: http://ti.me/iuu1CB

What do you think of this news?