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Kopi producenter klager over for store krav fra FDA


46788 akademikeren 28/9 2011 15:46
Oversigt

Ikke nok med at kopimedicinen ikke har forsket selv, nu klager de også over at deres produktion er underlagt for strenge krav. Bullshit siger jeg i lyset af at man har kvalt penge tilførslen til Biotek, skal man nu også give kopimedicinen ekstra gode vilkår i den anden ende. Giver ingen mening.

Work it out. Vil I have privatfinansieret forskning eller ej? Hvis ja, så lad vær med at ændre ligningen hele tiden for dem der rent faktisk har brugt milliarder og atter millarder af dollars på at udvikle medicinen, har brugt penge på at føre det igennem det ene mere fantasifulde fase 3 forsøg efter det andet. Fået godkendt sine fabrikker til UG. Og nu skal kopisterne så behandles bedre? Vor herre bevares!


Drug Shortages
FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. FDA is aware that in 2010 there was a record number of shortages and in 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs.
When quality/manufacturing issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, the FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients.
FDA works with other firms who manufacturer the drug, asking them to ramp up production, if possible, in order to prevent or mitigate a shortage.
FDA works to communicate information about shortages based on information provided by the manufacturers. Companies voluntarily provide the shortage information posted on the FDA website. Manufacturers are not required to report information about shortages to FDA, and are not required to report the reasons for shortages or the expected duration of shortages on the FDA website. FDA encourages and appreciates all reporting of shortages by manufacturers. Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.



28/9 2011 15:47 akademikeren 046789






28/9 2011 15:49 akademikeren 046790



PRESS RELEASE

GPhA Calls for Unprecedented Multi-Stakeholder Collaboration to Address Drug Shortages

Contact: David Belian 202-249-7124
WASHINGTON, D.C. (SEPT. 26, 2011) - The Generic Pharmaceutical Association (GPhA) today reaffirmed its dedication to working with all stakeholders to minimize current shortages of medically necessary drugs and mitigate factors that could contribute to future shortages.

In his first public policy presentation as President and CEO of GPhA, Ralph G. Neas told a Food and Drug Administration (FDA) drug shortages workshop that the generic pharmaceutical industry is resolute in its commitment to ensuring that lifesaving generic medications are available for all patients who rely on them.

"There can be no question that generic manufacturers are in the business of supplying medicine and assuring that consumers and patients have access to the drugs they need," Neas said. "That is our business model - to make quality medicines available and affordable to all."

"As members of the public, we, our employees and our families also are affected by shortages," he added. "I can state unequivocally that we are acutely aware of the distress caused to patients, families and clinicians by the shortage of medically necessary drugs."

Neas noted that the shortage crisis is a complex issue, and one that transcends the generic industry. Contrary to some media reports, shortages are typically not caused by a manufacturer's decision to voluntarily discontinue supplying the product. In addition, consolidation within the pharmaceutical industry has had little impact on shortages.

Causal factors, rather, are numerous and do not apply in every case. They include everything from an insufficient supply of raw materials to meet demand, to inadequate and delayed communications about shortages - both within the supply chain and within FDA. Other factors included changes in clinical practices that have altered volume production and use and stockpiling within the "grey market".

The solution, Neas said, will require all components of the supply and provider network - including brand manufacturers, active ingredient suppliers, component suppliers, wholesalers and distributors, group purchasing organizations, health care providers and the FDA among others - to cooperate in addressing the problem.

"We all have opportunities to partner in solving this problem," Neas said. "While many factors can cause drug shortages, the most serious shortages are often unexpected. We must work together to find solutions that focus both on current shortages and on minimizing the risk of future shortages."

"Indeed," Neas said, "this crisis compels unprecedented multi-stakeholder collaboration."

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 78 percent of the prescriptions dispensed in the U.S. but consume just 25 percent of the total drug spending. Additional information is available at gphaonline.org.



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