The FDA has approved Gilenya for use in slowing the progression of multiple sclerosis and reducing the frequency of disease relapses. The drug, developed by Novartis, becomes the first federally approved oral treatment for the debilitating disease, which affects 400,000 people in the US and more than 2 million people around the world.

Novartis had been in a race with Merck to be first-to-market with an effective oral treatment for multiple sclerosis, a disease that attacks the central nervous system and causes symptoms ranging from double vision to gait abnormalities and even stroke-like symptoms.

Marck’s anti-MS drug, cladribine, will be reviewed and possibly approved by the FDA before the end of this year.

Industry analysts and Novartis expect Gilenya to achieve at least $1 billion in annual sales.

Until the FDA green-lighted Gilenya, the only FDA-approved options for MS patients were intravenous drugs produced by Biogen Idec and Bayer. Biogen’s products, Avonex and Tysabri are leaders in MS market, which is estimated to be worth $8.6 billion per year.

“A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease,” Nicholas LaRocca, a VP at the National Multiple Sclerosis Society told BurrillReport.

In approving Gilenya, the FDA warned that patients who take the drug should be observed for slow heart rates shortly after therapy begins, and that the drug may be associated with infections.

For its part, Biogen Idec added in a statement that the long-term safety of Gilenya “has yet to be established.”

The mechanism of action of Gilenya remains unknown.  Many scientists believe it modulates a pathologic tendency for the body’s white blood cells to attack myelin, a fat-like substance that forms a protective sheath around nerve cells.

The Food and Drug Administration has sent letters to 5 electronic cigarette makers warning them that they are violating federal law.

e-Cigarettes vaporize liquid nicotine. The addictive chemical is then inhaled by users. Tobacco is not contained in these products.

In its warning letter, the FDA stated that e-cigarettes require FDA approval before they can be marketed, just like nicotine-laced gums, patches and lozenges.

Regulatory approval would depend on the results of clinical trials designed to assure the safety and effectiveness of e-cigarettes.

The companies in receipt of the letters were Ruyan America,  E-CigaretteDirect , E-Cig Technology, Gamucci America and Johnson’s Creek Enterprises. They have 15 days to respond.

More than 300 firms are believed to be involved in the production and distribution of e-cigarettes.

In response to the FDA’s warning, Ruyan America told the Wall Street Journal that it hasn’t distributed e-cigarettes since 2009, but that it would respond nevertheless. E-CigaretteDirect told the Journal it didn’t promote e-cigarettes for use in smoking cessation.

The other companies either didn’t respond or couldn’t be reached.

The FDA also cited E-Cig Technology for adding the erectile dysfunction drug tadalafil, and a non-FDA approved weight loss drug known as rimonabant in some of its products.

Michael Levy, a director in the FDA’s drug division, told the Journal his agency planned to review the companies’ responses before deciding what to do next. Regardless, the FDA will likely move to ban those tadalafil- and rimonabant-containing products from the market.

When it sent the letters, the FDA was actually opening a second theater in its battle with e-cigarette makers. Two years ago, the agency began detaining shipments of the products from China on grounds that they had not been approved by the agency as drug devices.

In the wake of the recent nationwide outbreak of salmonella that sickened 1,000 people and triggered the recall of a half-billion eggs, people have begun wondering just what that “USDA Grade A” badge on the sides of egg cartons actually means.

Remarkably, some believe the badge means a rabbi has blessed the eggs as kosher. Others assume it signifies the eggs are safe to eat; perhaps they even passed a test for pathogenic bacteria like salmonella.

Both suppositions are wrong, it turns out. What the badge actually means is that a “grader” from the US Department of Agriculture has checked the eggs at an egg-packing plant for size and color and assured that their shells were not cracked. That’s it.

Since the salmonella outbreak, officials at the USDA have redoubled their efforts to remind the public that their agency isn’t responsible for assuring the safety of the nation’s egg supply. That responsibility, the officials insist, belongs to the Food and Drug Administration

So what does the USDA do, exactly? Well, it regulates the safety of meats consumed in the US and it promotes US food products here and abroad. That badge on the egg cartons is a product of the second, marketing function of the USDA.

Commenting on the seemingly obvious idea that one government agency should be responsible for food safety, Connecticut Democrat Rosa DeLauro had this to say to the Wall Street Journal: “The USDA stamp should have a clear and consistent message to consumers—not a stamp of quality assurance that may be misinterpreted as a stamp of safety.”

Meanwhile, the FDA and the Justice Department are gathering outside the doors of the egg producers at the center of the recall. The FDA hasn’t decided whether it ought to have a badge of its own, by the way.

Last week, an FDA advisory panel narrowly supported a proposal by Eli Lilly & Co. to approve its blockbuster antidepressant Cymbalta for the treatment of chronic lower back pain.

Cymbalta has already been approved to treat fibromyalgia, anxiety and diabetic nerve pain. The drug is Lilly’s top-seller, having rung-up more than $3 billion in sales last year.

Before the vote, the committee reviewed FDA data showing that 2/3 of Cymbalta prescriptions written last year were for off-label uses, including headaches, musculoskeletal pain and non-diabetic nerve pain.

Regarding Lilly’s current proposal, 8 of the 14 members on the FDA’s anesthetic and life support drugs advisory committee voted “yes” in response to a question whether the FDA should green-light Cymbalta for the treatment of pain in a “broader population” than that which it has already approved.

The panel clarified that the FDA should approve Cymbalta for lower back pain but not for pain associated with osteoarthritis of the knee. In support of its decision, the panel noted that 2 out of 3 Lilly-funded studies of people with low back pain showed that Cymbalta provided significant pain relief over a 3-month period. In the case of osteoarthritis, only one out of two studies showed the drug reduced pain.

The FDA is not required to follow recommendations of its advisory committees, but it usually does.

Cymbalta carries a black-box warning from the FDA regarding the risk of suicide in children, adolescents and young adults. There are also warnings about liver damage, bleeding and adverse effects on blood pressure.

The FDA has approved ella, generically known as ulipristal, to prevent pregnancy up to 5 days following intercourse. That’s 2 days longer than Plan B, the emergency contraceptive currently on the market.

ella was developed by Paris-based HRA Pharma. It has been available in Europe since last year. It will be available in the US later this year, by prescription only. Watson Pharmaceuticals will distribute ella in the US.

The FDA green-lighted ella after reviewing the results of 2 studies. In the first, women who took the drug between 48 and 120 hours after sex experienced a 2.2% pregnancy rate, as compared to a rate of 5.5% among those who hadn’t taken ella. In the second study, women who took the drug within 72 hours after intercourse had a 1.9% pregnancy rate, as compared with an expected rate of 5.6%.

Plan B has been approved for the prevention of pregnancy up to 72 hours following intercourse. It is available without a prescription for women who are at least 17 years old. Younger teens must have a prescription for Plan B.

The FDA’s review of ella rekindled an old debate concerning the effects of emergency contraceptives. Antiabortion advocates argue that they can end pregnancies, not just prevent them.

“The bottom-line concern is that it’s a drug that causes an abortion,” Jeanne Monahan, director of the Family Research Council’s Center for Human Dignity told the Wall Street Journal.

However, the FDA-approved labeling for ella indicates the drug is an emergency contraceptive: it’s use is to prevent pregnancy. The drug works either by inhibiting or delaying ovulation, or by altering the lining of the uterus to hinder implantation of the fertilized egg.

“It’s used to prevent ovulation,” a Watson spokesman told the Journal. “It’s not an abortion drug.”

Recent, widespread dissemination of smartphones and improvements in wireless network coverage have created an opportunity for people to take a more active role in maintaining their health. It also permits physicians to remotely monitor patients and detect evolving health issues quickly and cheaply.

One potential impediment to such progress would be an overbearing regulatory environment which could slow innovation and discourage investment at a critical juncture in the evolution of the technologies.

To their credit, the Food and Drug Administration and the Federal Communications Commission have recognized this risk. Recently, the 2 agencies held a joint summit in which they tried to address the matter. During the summit, they agreed to cooperate on matters that cross their traditional domains, while focusing on ways to assure the safety and reliability of wireless medical devices and increase their availability to providers and consumers of health care.

“The American public–including industry, providers, patients, and other interested stakeholders–should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market,” the agencies said in a joint statement. “This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients.”

The summit was attended by leaders from healthcare, technology, academia, and the venture capital sector. 

“The relationship between FDA approval and FCC certification of wireless-enabled medical devices must be further delineated and expedited to overcome hurdles to innovation identified by both agencies,” Joseph Smith, the chief science officer for the West Wireless Health Institute said at the conference.

Venture capitalists welcomed the initiative.  “As an area of investment, this arena is challenging, due to the regulatory uncertainty,” said Jim Glasheen, a general partner at Technology Partners. “I am enthusiastically supportive that the FCC is working together with the FDA in taking a first-step towards a pro-investment/pro-innovation policy.”

Last month, a mix-up at the genetic testing company 23andMe caused 87 people to receive incorrect results. In one case, a woman was told her son carried genes for a life-threatening disorder when in fact, he didn’t. Another woman who thought she was white, was told her genes resembled those of an African American. In a third case, an actual woman was told she was a man.

23andMe said it regreted the mishap, spotted the error, notified people quickly, and took steps to assure the problem wouldn’t happen again.

The gaffe has focused attention on the question of whether the government should begin to regulate the burgeoning genetic testing industry more aggressively.

Supporters of this view argue that some companies in the space have made claims that are not supported by fact, and that the results of genetic testing are too complicated for people to interpret by themselves. People who are told they don’t have genes that put them at very high risk for developing breast cancer might stop getting mammograms, for example.

The flip-side to the argument is that a heavy dose of regulation might stifle innovation and render the tests too expensive and unnecessarily difficult to access. In addition, it’s far from clear that the FDA has the resources to verify the complex scientific claims being made by genetic testing companies.

Amid the debate, the FDA has begun to intervene. This spring, it blocked an effort by Pathway Genomics to market genetic tests in drug stores. Soon thereafter, it notified 5 companies that were marketing testing kits over the Internet that their tests were medical devices which needed to pass through normal regulatory processes.

Despite these early interventions, genetic testing remains in the Wild West phase of commercial development. Caveat emptor.

Earlier this summer, dozens of people reported that their boxes of Foot Loops and Apple Jacks contained strange odors and tastes. Some complained of nausea and diarrhea after consuming the cereal. The complaints prompted Kellogg to recall 28 million boxes of the iconic breakfast treats.

Kellogg subsequently blamed the problem on elevated levels of 2-methylnaphtalene, while adding that its experts found “no harmful material” in the cereals.

2-Methylnaphthalene may not be harmful, but it’s hard to know for sure. The FDA has no information about its impact on human health. Neither does the EPA, even though it has been asking the chemical industry to provide health information about 2-methylnaphtalene since 1994.

The EPA made the request 16 years ago because the chemical was being produced in massive quantities and finding its way into dozens, if not hundreds of consumer products.

The cereal recall has refocused attention on huge gaps in Federal regulators’ knowledge about chemicals in consumer products including food, children’s toys and clothing. According to the Washington Post, regulators don’t know squat about “the health risks posed by most of the 80,000 chemicals on the market today.”

The knowledge gap can be traced to the 1976 passage of the Toxic Substances Control Act which exempted 62,000 chemicals, including 2-methylnaphthalene, from regulatory oversight and stipulated that chemicals developed since then need not be tested for safety. Instead, manufacturers were encouraged to volunteer information concerning the health effects of their compounds and required to hand-over any data showing that a chemical harms health.

That created an enormous disincentive for manufacturers to test their chemicals.

Congress is working on legislation that would require companies to undertake health and safety assessments of existing chemicals and prove that new ones are safe before using them. The chemical industry thinks such laws could hamper innovation and competitiveness.

Pizaazz thinks it’ll take a US version of China’s melamine scandal before this legislation makes it to the President’s desk.

So-called pay-for-delay settlements involving generic and branded drug makers are becoming more common and costing consumers $3.5 billion each year, according to FTC Chairman John Liebowitz, who testified before Congress that he wanted to eliminate such agreements altogether.

These deals allow branded drug makers to sell their expensive products without generic competition for a period longer than the duration of the patents they hold on their drugs.

In the first 9 months of fiscal 2010, drug makers entered into 21 patent litigation settlements.  That’s more than the entire previous year.

“That’s almost an epidemic,” Leibowitz told BurrillReport. “Every single FTC Commissioner, going back through the Bush and Clinton administrations, has supported stopping these unconscionable agreements.”

The FTC supports legislation designed to halt pay-for-delay settlements. At the moment, this legislation is tucked into a Senate spending bill.

Both branded and generic drug companies would prefer to leave things just as they are. “The FTC’s testimony fails to present the whole story regarding patent settlements,” according to a statement released by the Generic Pharmaceutical Association. “Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired.”

The Pharmaceutical Research and Manufacturers of America, which represents branded drug makers, agreed. “A blanket ban could decrease the value of patents, remove an important option for a patent-holder’s defense of intellectual property, and reduce the incentives for future innovation of new medicines,” it said.

A Senate panel has already recommended banning pay-for-delay deals, but narrowly. Pennsylvania Democrat Arlen Specter introduced an amendment to remove the ban from the spending bill, but that amendment did not pass. The ban must pass the full Senate and House before becoming law.

Last week, 2 Iowa-based egg producers recalled more than half a billion eggs after federal investigators traced a recent salmonella outbreak to their production facilities. The outbreak began in May. So far, it has not been linked to any deaths.

The two companies are Wright County Egg, which recalled 380 million eggs that had been distributed across the nation, and Hillandale Farms, which recalled 170 million eggs that had been distributed to 14 states in the West and Midwest. According to the Washington Post, the companies use some of the same suppliers of feed and young chickens, a fact that may help investigators trace the source of the outbreak.

Hinda Mitchell, a spokesperson for Wright County Egg told the Post that her company “recognizes the significant consumer concern about the potential incidence of Salmonella Enteritidis…we continue to work cooperatively with FDA after our voluntary recall. This is consistent with our commitment to egg safety.”

It turns out that the Iowa-based DeCoster family owns or has close ties with both egg producers.

For what it’s worth, the Post reported yesterday that the family has a long history of run-ins with federal officials. In 1996 for example, another DeCoster-owned egg farm was dunned $3.6 million for health and safety violations after inspectors found employees handling dead chickens and manure with their bare hands.

Then, in 2001, Iowa’s Supreme Court cited the family as a “repeat violator” of its environmental laws, singling-out violations involving DeCoster’s hog-farms. Later that year, the family settled a complaint that company supervisors subjected 11 female workers to a “sexually hostile work environment,” including assault and rape.

What is more, in 2002 and again in 2008, OSHA cited the family for several violations that resulted in the exposure of workers to dangerous conditions.

Of course none of this is directly relevant to the salmonella outbreak…