FDA names along with shames drug makers to encourage generic competition

Pharmaceutical companies which spend billions of dollars to develop fresh drugs do not want competitors to profit by inexpensive generic copies of blockbuster medicines. To avoid rivals, they fight for patent extensions, seek fresh uses for old products along with, sometimes, prevent generic drug companies by obtaining samples.

Dr. Scott Gottlieb, the commissioner of the Food along with Drug Administration, calls This kind of “gaming the system,” along with has vowed to stop the item as part of the government’s campaign to lower drug prices.

On Thursday, the F.D.A. took a fresh tack along with began posting a list of makers of brand-name drugs which have been the target of complaints, to persuade them to “end the shenanigans,” from the commissioner’s words.

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Dr. Gottlieb calls the item transparency, although This kind of approach can be better known among ethicists as naming along with shaming.

Congressional efforts to force the companies to hand over samples of their drugs to generic competitors have not been successful. Recent proposals to ensure generic access to drug samples would likely save the federal government $3.8 billion over 10 years, according to the Congressional Budget Office, partly by lowering Medicare along with Medicaid spending on prescription drugs.

The Federal Trade Commission has also been investigating the practice.

Some brand-name drug makers say the legislation can be not needed. The F.D.A. has been speeding up approval of generic drugs, along with nearly 0 percent of prescriptions are filled with generic drugs.

although others point to the ways in which major pharmaceutical companies have managed to keep 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 along with test the item, to show which the item can be effective along with can be absorbed at the same rate as the brand drug, according to the agency. Both the F.D.A. along with the Federal Trade Commission say securing the samples can be difficult, because major drug firms can invoke safety concerns — real or unreal — to avoid providing the materials.

The F.D.A.’s fresh list includes drug companies the agency said may be pursuing gaming tactics to delay generic competition. Along with the name of each business, the agency noted how many inquiries the item received by generic drug companies seeking supplies. The names of the generic companies were not provided.

While Celgene tops the list, various other companies which the F.D.A. named as the subject of complaints included GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences along with Novartis Pharmaceuticals.

Celgene, which makes drugs to treat cancer along with immune-inflammatory diseases, was named as the subject of 31 inquiries by companies seeking access to Revlimid (lenalidomide), its treatment for multiple myeloma along with related diseases; Pomalyst (pomalidomide); along with Thalomid (thalidomide).

Celgene has been embroiled in lawsuits for several years with companies seeking access to the drugs. the item recently sued Dr. Reddy’s Laboratories Ltd., an Indian company, to block the item by selling generic copies of Revlimid, the company’s biggest product, along with has been fending off an attempt by Mylan to also get into the generic Revlimid business. At a court hearing last year, a lawyer for Mylan, Jonathan M. Jacobson, told a federal district judge which the drug costs dying patients $20,000 a month — a cost which would likely decline if generics were available.

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

“We have sold along with will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related along with business requirements,” Mr. Geissman said. “Generic versions of Thalomid along with Revlimid are required to enter the market in coming years.”

Geissman also said which Celgene supports federal efforts to promote access to samples at reasonable prices, as long as there can be appropriate safety along with liability protection for the seller.

The next biggest target, with 26 inquiries, can be Actelion Pharmaceuticals Ltd., a Johnson & Johnson company, which can be accused of blocking access to four drugs. There were 14 inquiries about getting supplies of Tracleer (bosentan), a medication prescribed for high blood pressure from the vessels of the lungs, known as pulmonary arterial hypertension. The F.D.A. also received eight complaints about lack of access to Opsumit (macitentan), which can be also used to treat pulmonary arterial hypertension. There were also several complaints about a lack of access to Actelion’s Zavesca (miglustat) along with Veletri (epoprostenol sodium). Veletri can be also used to treat pulmonary arterial hypertension along with Zavesca can be indicated for Gaucher disease.

An average one-month supply of Tracleer costs just over $12,000, along that has a supply of Opsumit runs $8,900 to $10,000, according to GoodRx, which tracks drug prices. Both prices are based on the patient presenting a free discount coupon.

Many pharmaceutical companies sell both brand-name along with generic drugs, leading to a situation in which a company like Mylan, still fighting Celgene in court, can be on the receiving end of generic company complaints.

The F.D.A.’s list of shame notes three inquiries by companies trying to get access to Mylan’s Amnesteem (isotretinoin), used to treat severe cystic acne which has not responded to antibiotic treatment.

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