Thursday, May 17, 2018

F.D.A. Names and Shames Drug Makers to Encourage Generic Competition

Pharmaceutical companies that spend billions of dollars to develop new drugs don't want competitors to take advantage of inexpensive generic copies of blockbuster medicines.

To avoid rivals, they fight for patent extensions, seek new uses for old products, and, sometimes, prevent drug companies from obtaining samples.

Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, calls this “gaming the system,” and has vowed to prevent it as a part of the government’s campaign to lower drug prices.

On Thursday, the F.D.A. took a replacement tack and commenced posting an inventory of makers of brand-name drugs that are the target of complaints, to influence them to “end the shenanigans,” within the commissioner’s words.

Dr. Gottlieb calls it transparency, but this approach is best known among ethicists as naming and shaming.

Congressional efforts to force the businesses handy over samples of their drugs to generic competitors haven't been successful.

Recent proposals to make sure generic access to drug samples would save the federal $3.8 billion over 10 years, consistent with the Congressional Budget Office, partly by lowering Medicare and Medicaid spending on prescribed drugs.

The Federal Trade Commission has also been investigating the practice.

Some proprietary drug makers say the legislation isn't needed. The F.D.A. has been speeding up approval of generic drugs, and nearly 90 percent of prescriptions are crammed with generic drugs.

But others point to the ways during which major pharmaceutical companies have managed to stay patents on certain expensive drugs for years longer than necessary.

Generic drug developers usually need between 1,500 to 5,000 units of the brand drug to develop their product and test it, to point out that it's effective and may be absorbed within the same rate because of the brand drug, consistent with the agency.

Both the F.D.A. and therefore the Federal Trade Commission says securing the samples are often difficult because major drug firms can invoke safety concerns — real or unreal to avoid providing the materials.

The F.D.A.’s new list includes drug companies the agency said could also be pursuing gaming tactics to delay generic competition.

Along with the name of every business, the agency noted what percentage inquiries it received from drug companies seeking supplies.

The names of the generic companies weren't provided.

While Celgene tops the list, other companies that the F.D.A. named because the subject of complaints included GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences, and Novartis Pharmaceuticals.

Celgene, which makes drugs to treat cancer and immune-inflammatory diseases were named because of the subject of 31 inquiries from companies seeking access to Revlimid (lenalidomide), its treatment for myeloma and related diseases; Pomalyst (pomalidomide); and Thalomid (thalidomide).

Celgene has been embroiled in lawsuits for several years with companies seeking access to the drugs.

It recently sued Dr. Reddy’s Laboratories Ltd., an Indian company, to dam it from selling generic copies of Revlimid, the company’s biggest product, and has been avoiding an effort by Mylan to also get into the generic Revlimid business.

At a court hearing last year, a lawyer for Mylan, Jonathan M. Jacobson told an administrative district judge that the drug costs dying patients $20,000 a month — a price that might decline if generics were available.

Greg Geissman, a spokesman for Celgene, said the corporate had not prevented generic companies from obtaining their products.

“We have sold and can sell our groundbreaking products to generic manufacturers for the needs of bioequivalence testing, subject to reasonable safety-related and business requirements,” Mr. Geissman said.

“Generic versions of Thalomid and Revlimid are expected to enter the market within the coming years.”

Geissman also said that Celgene supports federal efforts to market access to samples at reasonable prices, as long as there are appropriate safety and liability protection for the vendor.

The next biggest target, with 26 inquiries, is Actelion Pharmaceuticals Ltd., a Johnson & Johnson company, which is accused of blocking access to four drugs.

There were 14 inquiries about getting supplies of Tracleer (bosentan), a medicine prescribed for top vital signs within the vessels of the lungs referred to as pulmonary arterial hypertension.

The F.D.A. also received eight complaints a few lacks of access to Opsumit (macitentan), which is additionally wont to treat pulmonary arterial hypertension.

There were also several complaints a few lacks of access to Actelion’s Zavesca (miglustat) and Veletri (epoprostenol sodium).

Veletri is additionally wont to treat pulmonary arterial hypertension and Zavesca are indicated for Gaucher disease.

An average one-month supply of Tracleer costs just over $12,000, and therefore the supply of Opsumit runs $8,900 to $10,000, consistent with GoodRx, which tracks drug prices.

Both prices are supported by the patient presenting a free discount coupon.

Many pharmaceutical companies sell both brand-name and generic drugs, resulting in Many pharmaceutical companies sell both brand-name and generic drugs, resulting in a situation during which a corporation like Mylan, still fighting Celgene in court, are often on the receiving end of generic company complaints.

The F.D.A.’s list of shame notes three inquiries from companies trying to urge access to Mylan’s Amnesteem (isotretinoin), wont to treat severe cystic acne that has not skilled antibiotic treatment.


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